{"id":"F1996B00406","name":"Therapeutic Goods Regulations 1990","slug":"therapeutic-goods-regulations-1990","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":"394 of 1990","makingDate":null,"administeringDepartment":null,"currentVersion":{"id":28704,"registerId":"commonwealth-F1996B00406-current","compilationNumber":null,"startDate":"2026-04-01","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"Div 5","sectionType":"division","heading":"of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.","content":"  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## Division 1 Application of Part\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 4 Application of Part 2\n\n## 4A Interpretation\n\n## Division 3 General provisions about advertising therapeutic goods\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 6AA Prescribed committees\n\n## 6B Prohibited and required representations\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n## 7 Prescribed goods for advertising offence and civil penalty\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n## 7A Publisher exception for civil penalty provisions\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n## Division 4 Generic information about ingredients or components of therapeutic goods\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 8 Compliance with the Code\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n## Part 2A Patient information\n\n## 9A Information about certain therapeutic goods to be supplied\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n## 9B Information about therapeutic goods manufactured using human embryos\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n## Part 2C Australian Register of Therapeutic Goods\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## Division 2C.1 —Registered and listed therapeutic goods\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 10 Goods to be included in parts of the Register (Act s 9A)\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n## 10AAA Variation of entries in Register—registered complementary medicines and registered OTC medicines\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n## 10AAB Variation of entries in Register—prescription medicines other than biological medicines\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n## 10AAC Variation of entries in Register—biological medicines\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n## 10AAD Variation of entries in Register—biologicals\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n## 10AA Prescribed requests for variations of entries in Register\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n## 10AB Change of person in whose name goods are listed or registered\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n## 10AC Change of name of person\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n## 10B Transfers within the Register\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n## 10C Re‑assignment of registration or listing numbers\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n## 10D Notice of reassignment of registration or listing numbers\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n## Division 2C.2 —Medical devices included in the Register under Chapter 4\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 10E Goods to be included in part of the Register for medical devices (Act s 9A)\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n## 10F Change of person in relation to whom a medical device is included in the Register under Chapter 4 of the Act\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n## 10FA Change of name of person\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n## Division 2C.3 —Biologicals included in the Register\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 10G Goods to be included in the part of the Register for biologicals\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n## 10H Change of person for whom a biological is included in the Register under Part 3‑2A of the Act\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n## 10HA Change of name of person\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n## 10I Re‑assignment of biological numbers\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n## 10J Notice of reassignment of biological numbers\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n## Part 2CA Prohibition on import, export or manufacture of certain therapeutic goods—international agreements\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## Division 1 Prescribed international agreements\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 10JA Prescribed international agreements\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n## Division 2 Prohibition on importation of mercury\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n## Division 3 Prohibition on export of mercury\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 10JC Export of a therapeutic good that is mercury is prohibited unless approved by the Secretary before exportation\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n## Division 4 Applications to import or export mercury\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 10JD Applications to import or export mercury\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n## 10JE When approval may be granted—importation\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n## 10JF When approval may be granted—export\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n## Division 5 Mercury‑added products\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 10JG Import, export and manufacture of therapeutic goods that are mercury‑added products\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n## 10JH Manufacture of therapeutic goods containing mercury‑added products\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n## Part 2D Provisional determinations for medicine\n\n## 10K Applications for provisional determinations\n\n## 10L Provisional determinations\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n## Part 2E Scientific advice about aspects of quality, safety or efficacy of medicine\n\n## 10M Scientific advice about aspects of quality, safety or efficacy of medicine\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n## Part 2F Vaping goods\n\n## 10N Commercial quantity of vaping goods\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n## 10P Unit of vaping goods\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n## 10Q Permitted quantity\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n## Part 3 Registration, inclusion, listing and exemption of therapeutic goods\n\n## 11 Characteristics that separate and distinguish certain medicines from other therapeutic goods\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n## 11A Characteristics that separate and distinguish certain biologicals from other biologicals\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n## 12 Exempt goods\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n## 12A Unapproved medicines and biological—exemption in life‑threatening cases\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n## 12AAB Disposal of unused emergency goods and unused emergency biologicals\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n## 12AA Applications for special and experimental uses\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n## 12AB Goods imported etc for experimental uses\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n## 12AC Powers of authorised officers in relation to goods imported etc for experimental uses\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n## 12AD Use of goods for experimental purposes—specified conditions\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n## 12B Exemptions for certain uses—medicines\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n## 12BA Authorities for certain uses—therapeutic vaping substances that are not medicines\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n## 12C Exemptions for health practitioners—biologicals\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n## 15 Application of registration or listing number to goods\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n## 15AA Clinical trial registries\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n## 15A Conditions of registration and listing of medicines\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n## 16AA Information or documents that Secretary may require\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n## 16AB Specified periods\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n## Part 3A Applications for evaluation\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## Division 1 Preliminary\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 16A Interpretation—working day\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n## Division 1A Goods mentioned in Part 1 of Schedule 10\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 16C Applications for registration—notification of effectiveness and period for completing evaluations—general\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n## 16D Applications for variations—notification of effectiveness and period for deciding applications—general\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n## 16DA Conditions for periods for regulations 16C and 16D\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n## 16E Applications for variations—effect of failure to decide applications within specified period\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n## 16F Applications for variations—shorter period for deciding applications\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n## 16G Applications for registration—shorter period for completing evaluations\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n## Division 2 Applications for evaluation of substances\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 16GA Evaluation other than evaluation under subsection 9D(1), (2) or (3) or section 25 of the Act\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n## Division 3 Class 2, Class 3 and Class 4 biologicals\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n## 16GD Notification of effective request and period within which certain applications must be decided\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n## 16GE Failure to decide an application within specified time\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n## 16GF Evaluation, other than evaluation under subsection 9D(3A) or (3AA) or section 32DE of the Act\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n## Division 4 Complementary medicines and certain other listed medicines\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n## 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n## 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n## 16GIA Period for paying evaluation fee for application under subsection 26BD(1) of the Act\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n## 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n## Part 3B Designated orphan drugs\n\n## 16H Application to designate medicine as orphan drug\n\n## 16J Designation of medicine as orphan drug\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n## 16K Period during which designation is in force\n\n## 16L Extension of designation\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n## 16M Revocation of designation\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n## Part 3C Therapeutic goods (priority applicant) determinations\n\n## 16P Application of Part\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n## 16Q Application for therapeutic goods (priority applicant) determination\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n## 16R Making of therapeutic goods (priority applicant) determination\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n## 16S Period during which therapeutic goods (priority applicant) determination is in force\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n## 16T Revocation of therapeutic goods (priority applicant) determination\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n## Part 3D Biologicals (priority applicant) determinations\n\n## 16U Application of Part\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n## 16V Application for biologicals (priority applicant) determination\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n## 16W Making of biologicals (priority applicant) determination\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n## 16X Period during which biologicals (priority applicant) determination is in force\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n## 16Y Revocation of biologicals (priority applicant) determination\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n## Part 4 Licensing of manufacturers\n\n## 17 Exempt goods for the purposes of subsection 34(1) of the Act\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n## 18 Exempt Persons\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n## 19 Requirements for licence holders\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n## 20 Conditions of licences\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n## 21 Persons having control of production etc to be named\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n## 22 Transfer of licences\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n## Part 5 Testing of goods\n\n## 23 Purpose of this Part\n\n## 24 Nomination of analysts\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n## 25 Testing of samples of goods\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n## 26 Certificate of analyst\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n## Part 5A Exceptional release\n\n## 33A Prescribed circumstances under which biologicals may be imported, exported or supplied\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n## 33B Conditions for supply of biologicals\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n## 33C Report on release of nonconforming biological\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n## Part 6 Committees\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## Division 1A Advisory Committee on Medicines\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 35 Establishment\n\n## 35A Functions\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n## 35B Membership\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n## Division 1D Advisory Committee on Medical Devices\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 38 Establishment\n\n## 38A Functions\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n## 38B Membership\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n## Division 1E Advisory Committee on Complementary Medicines\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 39 Establishment\n\n## 39A Functions\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n## 39B Membership\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n## Division 1EA —Advisory Committee on Biologicals\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 39C Establishment\n\n## 39D Functions\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n## 39E Membership\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n## Division 1EB —Advisory Committee on Vaccines\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 39F Establishment\n\n## 39G Functions\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n## 39H Membership\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n## Division 1F General\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 40 Application of this Division\n\n## 41 Appointment of members\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n## 41A Appointment of the chair\n\n## 41B Resignation or vacancy\n\n## 41C Termination of appointment\n\n## 41D Leave of absence\n\n## 41E Acting members\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n## 41F Committee procedures\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n## 41G Meetings\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n## 41H Presiding member\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n## 41I Quorum\n\n## 41J Voting\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n## 42 Miscellaneous\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n## Division 3A Advisory Committee on Medicines Scheduling\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## Subdivision 3A.1 Preliminary\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 42ZCA Definitions for Division 3A\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n## Subdivision 3A.2 Constitution of Committee\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 42ZCB Membership of Committee\n\n## 42ZCC Committee members\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n## 42ZCD Appointed members\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n## 42ZCE Nominated members\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n## 42ZCF Appointment of the Chair and acting Chair\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n## 42ZCG Resignation or vacancy\n\n## 42ZCH Termination of appointment\n\n## 42ZCI Leave of absence\n\n## 42ZCJ Acting members\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n## Subdivision 3A.3 Committee meetings\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 42ZCK Committee meetings\n\n## 42ZCL Meeting procedure\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n## 42ZCM Presiding member\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n## 42ZCN Quorum\n\n## 42ZCO Voting\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n## 42ZCP Miscellaneous\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n## Division 3B Advisory Committee on Chemicals Scheduling\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## Subdivision 3B.1 Preliminary\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 42ZCQ Definitions for Division 3B\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n## Subdivision 3B.2 Constitution of Committee\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 42ZCR Membership of Committee\n\n## 42ZCS Committee members\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n## 42ZCT Appointed members\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n## 42ZCU Nominated members\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n## 42ZCV Appointment of the Chair and acting Chair\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n## 42ZCW Resignation or vacancy\n\n## 42ZCX Termination of appointment\n\n## 42ZCY Leave of absence\n\n## 42ZCZ Acting members\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n## Subdivision 3B.3 Committee meetings\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 42ZCZA Committee meetings\n\n## 42ZCZB Meeting procedure—general\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n## 42ZCZC Presiding member\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n## 42ZCZD Quorum\n\n## 42ZCZE Voting\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n## 42ZCZF Miscellaneous\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n## Division 3C Joint meetings\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 42ZCZG Joint meetings\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n## 42ZCZH Procedure for joint meetings\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n## Division 3D Procedure for amending the current Poisons Standard\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## Subdivision 3D.1 Preliminary\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 42ZCZI Definitions for Division 3D\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n## Subdivision 3D.2 Procedure if proposed amendment referred to expert advisory committee\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 42ZCZJ Application\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n## 42ZCZK Proposed amendment to be referred to expert advisory committee\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n## 42ZCZL Consideration of public submissions\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n## 42ZCZM Committee to advise Secretary\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n## 42ZCZN Interim decision of Secretary\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n## 42ZCZO Secretary may make final decision if no interim decision required\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n## 42ZCZP Call for further submissions\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n## 42ZCZQ Reconsideration of interim decision\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n## 42ZCZR Final decision if there is an interim decision\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n## 42ZCZS Publication of final decision\n\n## Subdivision 3D.3 Procedure if proposed amendments not referred to expert advisory committee\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 42ZCZT Application\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n## 42ZCZU Final decision without interim decision\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n## 42ZCZV Interim decision required if Secretary decides not to amend as requested\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n## 42ZCZW Final decision if there is interim decision\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n## 42ZCZX Publication of final decision\n\n## Part 7 Charges for registration, listing and inclusion, licences, exemptions, costs and fees\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## Division 1 Charges for registration, listing and inclusion of therapeutic goods, exemptions and licences\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## Subdivision 1 Preliminary\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 43AAA Meaning of turnover and when turnover is of low value\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n## Subdivision 1A Time for payment of certain annual charges\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 43AAB Time for payment of certain annual charges\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n## Subdivision 2 Exemption from liability to pay certain annual charges—therapeutic goods other than IVD devices\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 43AAAA Application\n\n## 43AABA Purpose of this Subdivision\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n## 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n## 43AAC Exemption from liability to pay certain annual charges—2015‑16 financial year\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n## 43AAD Exemption from liability to pay certain annual charges—financial years commencing on or after 1 July 2016\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n## 43AAE Exemption from liability to pay certain annual charges—late notice that turnover was of low value\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n## 43AAF Person may notify Secretary that turnover of goods for financial year will not be of low value\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n## 43AAG Secretary may notify person that annual charge is payable if turnover is not of low value\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n## Subdivision 2A Exemption from liability to pay annual charge—IVD devices\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 43AAGA Purpose of this Subdivision\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n## 43AAGB Exemption from liability to pay annual charge—2017‑18 financial year\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n## 43AAGC Exemption from liability to pay annual charge—financial years commencing on or after 1 July 2018\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n## 43AAGD Exemption from liability to pay annual charge—late notice that turnover was of low value\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n## 43AAGE Person may notify Secretary that turnover of IVD device for financial year will not be of low value\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n## 43AAGF Secretary may notify person that annual charge is payable if turnover is not of low value\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n## Subdivision 2B Waiver of certain annual charges\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 43AAGG Purpose of Subdivision\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n## 43AAH Waiver of certain annual charges\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n## Subdivision 3 Charges for licensing\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 43AAJ Licensing charge—reduction in certain circumstances\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n## Division 2 Fees and costs\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 43 Fees\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n## 43A When is no application fee payable?\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n## 43AA Fee for evaluation—refund in certain circumstances\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n## 43AB Circumstances in which inspection fee covered by annual charge\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n## 43AC Refund of fees where no evaluation undertaken—registered OTC medicines\n\n## 43ACA Refund of fees where no evaluation undertaken—certain registered and listed medicines\n\n## 43AD Fee for therapeutic goods (priority applicant) determination application—refund in certain circumstances\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n## 43AE Fee for application for provisional determination relating to medicine—refund in certain circumstances\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n## 43AF Fee for request for variation of certain registered and listed medicines—refund in certain circumstances\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n## 43AG Refund of fees for certain requests relating to conditions for therapeutic goods in the Register\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n## 44 Testing of samples—recovery of costs\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n## 45 Waiver or reduction of fees\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n## 45AA Payment of fees in instalments\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n## Part 8 Miscellaneous\n\n## 46AA Identity cards for authorised officers\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n## 46A Delegation under the Act\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n## 46B Protected persons\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n## 46 Release of information\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n## 47 Delegation—powers and functions under these Regulations\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n## 47A Delegation—powers under paragraphs 19(1)(a), 32CK(1)(d) and 41HB(1)(d) of the Act\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n## 47B Provision of information concerning medicines, biologicals and medical devices\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n## 47C Enforceable directions\n\n## 48 Review of decisions\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n## Part 9 Transitional\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## Division 1 Transitional provisions relating to the Therapeutic Goods Amendment Regulations 2010 (No. 1)\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 48A Definitions\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n## 48B Application of 2010 Amendment Regulations\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n## Division 2 Transitional provisions relating to the Therapeutic Goods Amendment Regulation 2012 (No. 3)\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 49 Transitional\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n## Division 3 Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 50 Application\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n## Division 4 Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 51 Application\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n## Division 5 Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 52 Definitions\n\n## 53 Transitional—continuing application of evaluation fees for variations of permissible ingredients determinations\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n## 54 Transitional—existing orphan drug designations\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n## 55 Transitional—pending orphan drug designation applications\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n## 56 Transitional—fee waivers in relation to certain designations\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n## Division 6 Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 57 Definitions\n\n## 58 Application—statements in relation to unapproved medicines and biologicals\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n## 59 Transitional—approval of form for statements\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n## Division 7 Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 60 Application provisions\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n## 61 Operation of Schedule 2—complementary medicines\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n## 62 Saving provision\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n## Division 8 Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 63 Application of amendments\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n## Division 9 Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 64 Definitions\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n## 65 Transitional provisions—exemptions from Parts 3‑2 and 3‑2A of the Act\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n## 66 Transitional provisions—exemptions from Part 3‑3 of the Act\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n## Division 10 Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 67 Application\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n## Division 11 Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 68 Application and transitional provisions\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n## Division 12 Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## Subdivision A Definitions\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 69 Definitions\n\n## Subdivision B Faecal microbiota transplant products\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 70 Faecal microbiota transplant products—Division 4 of Part 3‑2A of the Act\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n## 71 Faecal microbiota transplant products—Part 3‑3 of the Act\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n## Subdivision C Consumer medicine information documents\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 72 Consumer medicine information documents\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n## Subdivision E Fee waivers and refunds for certain requests relating to prescription opioids\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 74 Fee waivers and refunds for certain requests relating to prescription opioids\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n## Subdivision F Clinical trials\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 75 Clinical trials\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n## Division 13 Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 76 Approving supply of therapeutic goods under authorised prescriber scheme\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n## 77 Preliminary assessment of applications for variation of permissible ingredients determination\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n## Division 15 Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 79 Application of amendments made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n## Division 16 Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 81 Access to medicines in emergency situations\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n## 82 Consumer medicine information documents\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n## 83 Approving supply of therapeutic goods under authorised prescriber scheme\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n## Division 17 Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 84 Amendments made by Division 1 of Part 2 of Schedule 1\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n## 85 Amendments made by Division 2 of Part 2 of Schedule 1\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n## Division 18 Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 86 Extemporaneously‑compounded medicinal cannabis products\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n## Division 19 Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 87 Reconsideration of decisions\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n## Division 20 Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 88 Exempt goods\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n## 89 Fee for requests to vary entries in Register\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n## Division 21 Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 90 Clinical trials\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n## Division 22 Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 91 Clinical trials\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n## 92 Removal of exemptions for sunscreen preparations\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n## Division 23 Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 93 Definitions\n\n## 94 Approving supply of therapeutic goods under authorised prescriber scheme\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n## 95 Goods to be included in parts of the Register\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n## 96 Exempt goods\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n## 97 Transitional vaping manufacturers—exemption from Part 3‑3 of the Act\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n## Division 24 Application provision relating to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 98 Exempt goods\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n## Division 25 Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 99 Definitions\n\n## 100 Fee waivers in relation to the Medicines Repurposing Program\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n## 102 Identity cards\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n## 103 Sunscreen preparations\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n## Division 26 Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 104 Definitions\n\n## 105 Authorities for therapeutic vaping substances that are not medicines\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n## 106 Therapeutic vaping packs\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n## 107 Exempt goods\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n## 108 Transitional vaping goods—exemption from Part 3‑2 of the Act\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n## Division 27 Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 109 Definitions\n\n## 110 Exempt therapeutic goods\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n## 111 Notices, statements and determinations\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n## Division 28 Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> active ingredient, for a medicine, means a therapeutically active component in the medicine’s final formulation that is responsible for its physiological or pharmacological action.\n\n> AHPRA number, of a health practitioner, means the registration number published by the Australian Health Practitioner Regulation Agency in relation to the health practitioner.\n\n> Australian Approved Names List means the document entitled Australian Approved Names List for Therapeutic Substances, as in force from time to time, published by the Therapeutic Goods Administration.\n\n> Note 2: The Australian Approved Names List may be published as part of a larger document, for example, the document entitled TGA Approved Terminology for Therapeutic Goods.\n\n> authorised officer, in relation to a provision of these Regulations, means an officer authorised by the Secretary to exercise powers under that provision.\n\n> Note: Regulation 2A provides for the Secretary to authorise certain officers to exercise powers under provisions of these Regulations.\n\n> changes table means the table published on the Department’s website for the purposes of this definition, as in force from time to time.\n\n> Class 1 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 1 biological.\n\n> Class 4 biological means a biological (other than an export only biological) that is mentioned in Schedule 16 as a Class 4 biological.\n\n> complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.\n\n> designated active ingredients, for a complementary medicine, means an active ingredient, or a kind of active ingredient, mentioned in Schedule 14.\n\n    (a) that is a vaping device of the kind referred to in paragraph (a) of the definition of vaping device in subsection 41P(1) of the Act; and\n    (b) that is fully assembled with all the constituent components fixed permanently in place and that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be disassembled; and\n    (d) that is not designed or intended (by the person under whose name the vaping device is or is to be supplied) to be refilled.\n\n> expiry date, for therapeutic goods, means the date (expressed as the month and year) after which the goods should not be used.\n\n> generic product means a medicine that, in comparison to a registered medicine or a medicine that has been registered but is no longer a registered medicine (the comparison medicine):\n\n    (a) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the comparison medicine; and\n\n> herbal substance means all or part of a plant or substance (other than a pure chemical or a substance of bacterial origin):\n\n    (a) that is obtained only by drying, crushing, distilling, extracting, expressing, comminuting, mixing with an inert diluent substance or another herbal substance or mixing with water, ethanol, glycerol or aqueous ethanol; and\n    (b) that is not subjected to any other treatment or process other than a treatment or process that is necessary for its presentation in a pharmaceutical form.\n\n> high level disinfectant means a disinfectant that kills all microbial pathogens, except bacterial endospores, when used as recommended by its manufacturer.\n\n    (a) formulated for use on the principle that it is capable of producing in a healthy person symptoms similar to those which it is administered to alleviate; and\n\n> immediate family, in relation to a person, means the parents, grandparents, spouse, de facto spouse, child or ward of that person.\n\n> IN1 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety and quality of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n    (i) the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN2 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (a) an evaluation of the safety of an ingredient based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; and\n\n> IN3 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires:\n\n    (i) evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ; or\n\n> IN4 application means an application made under subsection 26BD(1) of the Act for a recommendation to vary a section 26BB determination, if the variation is of a kind that requires an evaluation of the safety and quality of an ingredient that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> independent evaluation means an evaluation that is not based on an evaluation report from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)1 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if the medicine is identical to a medicine listed under section 26AE of the Act (disregarding differences between presentation, colour, flavour or fragrance).\n\n> L(A)2 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (a) the application is for a medicine that, in comparison to a medicine (the included medicine) that is or was listed under section 26AE of the Act:\n    (i) has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the included medicine; and\n    (b) the application requires an evaluation of the efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n> L(A)3 application means an application made under section 23 of the Act to list a medicine under section 26AE of the Act, if:\n\n    (ii) the application is for a medicine that is listed under section 26AE of the Act and is for a different active ingredient, indication, dosage form, strength or excipient; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C1 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)C2 (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n    (a) is of information included in an entry in the Register relating to a medicine that is listed under section 26AE of the Act; and\n\n> L(A)CN (section 23) application means an application made under section 23 of the Act for the listing under section 26AE of the Act of a medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> medicinal cannabis products means therapeutic goods that contain, or are manufactured from, any part of a plant of the genus Cannabis (including, for example, the flowers, fruiting tops, seeds, stems and leaves of the plant).\n\n> mercury means elemental mercury (Hg(0), CAS No. 7439‑97‑6), and includes mixtures of mercury (including alloys of mercury) with a mercury concentration of at least 95% by weight, but does not include non‑Minamata mercury.\n\n> mercury‑added products means the products listed in Part I of Annex A to the Minamata Convention that contain mercury, but does not include:\n\n> Minamata Convention means the Minamata Convention on Mercury done at Minamata on 10 October 2013, as in force for Australia from time to time.\n\n> Note: The Convention could in 2021 be viewed in the Australian Treaties Library on the AustLII website (http://www.austlii.edu.au).\n\n> mother tincture means a preparation prepared by the process of solution, extraction or trituration to prepare homoeopathic preparations.\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another medicine that is included in the Register; and\n\n    (a) has the same chemical, biological or radiopharmaceutical active ingredient (or fixed combination of such ingredients) as another prescription medicine included in the Register; and\n\n    (a) a chemical, biological or radiopharmaceutical active ingredient that has not previously been included in an entry in the Register; or\n    (b) a fixed combination of chemical, biological or radiopharmaceutical active ingredients at least one of which has not previously been included in an entry in the Register.\n\n> nonconforming biological means a biological that is included in the Register under Part 3‑2A of the Act but does not conform with:\n\n> open shelf life, for therapeutic goods, means the time, after the container holding the goods is opened, after which the goods should not be used.\n\n> pharmaceutical benefit means a Commonwealth pharmaceutical benefit under the National Health Act 1953 or the Veterans’ Entitlements Act 1986.\n\n> principal investigator, in relation to a clinical trial of therapeutic goods, means the person who is in charge of the conduct of the trial.\n\n> RCM1 application means an application made under section 23 of the Act to register a complementary medicine, if the medicine is identical to registered goods (disregarding differences between presentation, colour, flavour or fragrance).\n\n> RCM2 application means an application made under section 23 of the Act to register a complementary medicine, if the application requires an evaluation of the safety, quality and efficacy of the medicine based on evaluation reports from a competent regulatory authority of a foreign country or foreign jurisdiction determined under regulation 16GJ.\n\n    (a) the application is for a generic product for which bioequivalence data is not needed for the purposes of evaluation of the medicine; or\n\n    (b) the application is for a generic product for which bioequivalence data is needed for the purposes of evaluation of the medicine; or\n\n    (ii) the application is for a medicine that is registered and is for a new dosage form of the medicine, a new active ingredient of the medicine, an increase in the strength of an active ingredient of the medicine or the addition of an excipient not used in complementary medicines at the time the application is made; and\n\n> RCMC1 (section 9D) request means a request made under subsection 9D(1), (2) or (3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC1 (section 9D) level change.\n\n> RCMC1 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC2 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC2 (section 9D) level change.\n\n> RCMC2 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC3 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC3 (section 9D) level change.\n\n> RCMC3 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> RCMC4 (section 9D) request means a request made under subsection 9D(3) of the Act to vary information in the Register for a registered complementary medicine, if the variation is of a kind specified in the changes table as an RCMC4 (section 9D) level change.\n\n> RCMC4 (section 23) application means an application made under section 23 of the Act to register a complementary medicine (the new medicine), if:\n\n    (b) the new medicine and the existing medicine are separate and distinct for the purposes of Part 3‑2 of the Act, but the new medicine forms part of the same gazetted therapeutic goods group as the existing medicine; and\n\n> Required Advisory Statements for Medicine Labels means the advisory statements specified by the Minister by legislative instrument under subsection 3(5A) of the Act.\n\n> serious, in relation to a form of a disease, condition, ailment or defect, means a form of the disease, condition, ailment or defect that is:\n\n    (a) generally accepted as not being appropriate to be diagnosed or treated without consulting a suitably qualified health care professional; or\n    (b) generally accepted to be beyond the ability of the average person to evaluate accurately, or treat safely, without regular supervision by a suitably qualified health care professional.\n\n> sterilant means a chemical agent that kills microbes with the result that the sterility assurance level of a microbial survivor is less than 10‑6.\n\n> TGA notifications process guidance document means Version 4.0 of the document published by the Therapeutic Goods Administration entitled Notifications process—requests to vary biologicals and registered medicines where quality, safety and efficacy are not affected (as in force on 21 June 2023).\n\n> Note: The TGA notifications process guidance document could in 2023 be viewed on the Therapeutic Goods Administration’s website (http://www.tga.gov.au).\n\n> therapeutic vaping device accessory has the same meaning as in the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> therapeutic vaping substance means a therapeutic good that is a liquid or other substance designed or intended for use in or with a vaping device.\n\n    (a) is well documented, or otherwise established, according to the accumulated experience of many traditional health care practitioners over an extended period of time; and\n\n> turnover of therapeutic goods, for Division 1 (other than Subdivision 3) of Part 7, has the meaning given by subregulation 43AAA(2).\n\n  The Secretary may, in writing, authorise any of the following persons to exercise powers under a specified provision of these Regulations:\n\n  (3) For the definition of corresponding State law in subsection 3(1) of the Act, each of the following State laws is declared to correspond to the Act and the Regulations:\n\n    (i) the medicine’s label does not contain the advisory statement specified by the Minister under subsection 3(5A) of the Act for the medicine;\n    (ii) the Secretary has given consent, under sections 14 and 14A of the Act, for the medicine to be imported into, exported from or supplied in Australia without the advisory statement mentioned in subparagraph (i);\n    (ii) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; or\n    (ii) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to indications—none of the requirements have been contravened.\n\n  (1) For paragraph 3(5)(e) of the Act, any labelling, packaging or presentation of therapeutic goods (including novelty dosage forms in the shape of animals, robots, cartoon characters or other similar objects) that is likely to result in those goods being mistaken for or confused with confectionery or toys is an unacceptable presentation of the goods.\n  (2) For paragraph 3(5)(e) of the Act, the presentation of therapeutic goods is unacceptable if the name applied to the goods is not sufficiently distinctive to allow for the identification of the goods for the purposes of recall.\n\n  (3) The goods have been subjected to minimal manipulation if no process or processes to which the goods have been subjected have altered any of the biological characteristics, physiological functions or structural properties of the original cells or tissues that are relevant to the purpose for which the manufacturer of the goods intends the goods to be used.\n  (4) Homologous use of the goods is use of the goods to repair, reconstruct, replace or supplement the cells or tissues of a person (the recipient), if the goods will perform the same basic function or functions in the recipient as the original cells or tissues performed in the person from whom they were collected.\n\n  (2) For subsection 42DJ(2) of the Act, the representations in column 2 of an item in Part 2 of Schedule 2 about therapeutic goods in column 3 of that item are required representations.\n\n    (b) a medical device, or a kind of medical device, that is the subject of an approval under section 41HB of the Act or an authority under section 41HC of the Act;\n    (f) a kind of medical device mentioned in item 1.1 in Part 1 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (g) a kind of medical device mentioned in column 2 of an item in Part 2 of Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002 (except items 2.12, 2.13, 2.14 and 2.15 of that Part);\n    (h) a kind of medical device covered by an exemption under regulation 7.2 of the Therapeutic Goods (Medical Devices) Regulations 2002;\n    (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act;\n    (i) are, or contain, a substance that is included in Schedule 3, 4 or 8 to the current Poisons Standard and is not included in Appendix H to the current Poisons Standard; and\n\n  For the purposes of paragraphs 42DLB(10)(a) and 42DMA(2)(a) of the Act, a kind of person is a publisher of a print edition of a newspaper or magazine that is or was available to the public by way of purchase in Australia.\n\n  For section 42DO of the Act, sections 8, 9, 10, 11, 12, 24 (to the extent that it relates to endorsements) and 26 of the Therapeutic Goods Advertising Code are prescribed.\n\n  (1) The sponsor of therapeutic goods that are specified in Part 1 of Schedule 10 and are included in the Register must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 12.\n\n> Note: Additional information must be provided in relation to certain therapeutic goods (other than medical devices) that are manufactured using a human embryo or human embryonic stem cell, or any other material sourced from a human embryo or human embryonic stem cell—see regulation 9B.\n\n  (1AAA) For subregulation (1), strict liability applies to the physical element that the goods are specified in Part 1 of Schedule 10.\n\n  (1AA) It is a defence to a prosecution under subregulation (1) if the goods are specified in Schedule 3 to the Poisons Standard.\n\n> Note: A defendant bears an evidential burden in relation to the matters mentioned in subregulation (1AA) (see section 13.3 of the Criminal Code).\n\n  must not supply the goods if the sponsor does not supply with the goods written information about the goods that meets the requirements for a consumer medicine information document set out in Schedule 13.\n\n  (1B) For the purposes of an offence under subregulation (1A), strict liability applies to the physical element mentioned in paragraph (1A)(a).\n\n    (b) in another manner that will enable the information to be given to a person to whom the goods are administered or otherwise dispensed.\n\n    (b) the sponsor knows the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell; and\n    (d) on or after 1 July 2004, the goods are included in the part of the Register for goods known as registered goods or in the part of the Register for goods known as provisionally registered goods; and\n    (e) the goods are supplied without written information stating that the goods were manufactured using a human embryo or human embryonic stem cell, or other material sourced from a human embryo or human embryonic stem cell.\n\n> human embryo means a live embryo that has a human genome or an altered human genome and that has been developing for less than 8 weeks since the appearance of 2 pro‑nuclei or the initiation of its development by other means.\n\n> human embryonic stem cell means undifferentiated cells derived from a human embryo that have the potential to become a wide variety of specialised cell types.\n\n  (5) For the purposes of the definition of human embryo in subregulation (4), in working out the length of the period of development of a human embryo, any period when the development of the embryo is suspended is to be disregarded.\n\n    (a) subject to paragraph (aa), therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register are to be included in the part of the Register for goods known as registered goods; and\n    (aa) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 3 that are included in the Register as mentioned in paragraph 29(2)(c) of the Act are to be included in the part of the Register for goods known as provisionally registered goods; and\n    (b) therapeutic goods, and classes of therapeutic goods, of a kind mentioned in Schedule 4 that are included in the Register are to be included in the part of the Register for goods known as listed goods.\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a registered complementary medicine or registered OTC medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—registered complementary medicines and registered OTC medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a flash including the term “new” or “value pack” to a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the name of the medicine’s sponsor is not included in the name of the medicine, a change to the sponsor’s details (including the sponsor’s logo) that are included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the recommended storage conditions for the medicine that are included in a label or package insert for the medicine if the change makes the conditions more restrictive</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A decrease in the shelf life of the medicine included in a label or package insert </span><span style=\"font-family:Cambria, serif\">for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AOV</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the type of starch (if any) used as an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QFP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) if the specifications for the starting materials of the medicine incorporate a default standard—the replacement of that default standard with another default standard;</span></p><p class=\"Tablea\"><span>(b) if the specifications for the starting materials of the medicine include in</span><span>‑</span><span>house tests—the replacement of those tests with a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>QSP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a blister pack, any of the following changes to a material from which the blister pack is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polyvinyl chloride—a change to:</span></p><p class=\"Tablei\"><span>(i) a material consisting of polyvinyl chloride and polyvinylidene chloride; or</span></p><p class=\"Tablei\"><span>(ii) a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(b) if the material consists of polyvinyl chloride and polyvinylidene chloride—a change to a material consisting of polyvinyl chloride and polychlorotrifluoroethylene;</span></p><p class=\"Tablea\"><span>(c) if the material is used in a plastic component of the blister pack—a change to a material with demonstrated equal or lesser water permeability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, and the container is a bottle, any of the following changes to a material from which the bottle is made:</span></p><p class=\"Tablea\"><span>(a) if the material is polystyrene—a change to polyvinyl chloride, polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(b) if the material is polyvinyl chloride—a change to polyethylene, polypropylene or glass;</span></p><p class=\"Tablea\"><span>(c) if the material is polyethylene:</span></p><p class=\"Tablei\"><span>(i) an increase in the material’s density; or</span></p><p class=\"Tablei\"><span>(ii) a change to glass, or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(d) if the material is glass—a change to polyethylene of a density of at least 0.95 grams per cubic centimetre or polypropylene of a density of at least 0.89 grams per cubic centimetre;</span></p><p class=\"Tablea\"><span>(e) if the material is polypropylene of a density of at least 0.89 grams per cubic centimetre—a change to glass, or polyethylene of a density of at least 0.95 grams per cubic centimetre</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KBT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the closure system for the medicine, unless:</span></p><p class=\"Tablea\"><span>(a) the closure system also functions as a metering component of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the change involves a change to the pump, or components of the pump, of a metered</span><span>‑</span><span>dose aerosol</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If a refill pack had previously been supplied with the medicine, the supply of the medicine without the refill pack</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KRR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the performance of an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is non</span><span>‑</span><span>sterile, the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of the medicine by a manufacturer</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MMD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the number of steps in the manufacture of the medicine performed by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the font, letter height or text size on a label for the medicine, other than a change on the main label for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LFT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Removal of a graphic from a label for the medicine, other than a graphic that relates to directions for:</span></p><p class=\"Tablea\"><span>(a) use of the medicine; or</span></p><p class=\"Tablea\"><span>(b) use of a measuring device; or</span></p><p class=\"Tablea\"><span>(c) use of an applicator</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RGN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the location of a graphic on the panel of a label for the medicine if:</span></p><p class=\"Tablea\"><span>(a) there is no change to the size, shape or colour of the graphic; and</span></p><p class=\"Tablea\"><span>(b) the change does not involve reformatting text</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LGM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is in a liquid or semi</span><span>‑</span><span>solid dosage form, the addition of a new pack size that is within the pack size range for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PLN</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The deletion of a pack size for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the medicine is sterile:</span></p><p class=\"Tablea\"><span>(a) the addition of a manufacturer of the medicine for the performance of any of the following steps:</span></p><p class=\"Tablei\"><span>(i) release for supply;</span></p><p class=\"Tablei\"><span>(ii) secondary packaging;</span></p><p class=\"Tablei\"><span>(iii) chemical, physical or microbial testing; or</span></p><p class=\"Tablea\" style=\"page-break-after:avoid\"><span>(b) the inclusion of the performance of any of the steps mentioned in paragraph</span><span> </span><span>(a) as an additional step in the manufacture of the medicine by a manufacturer of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>If a measuring device had previously been supplied with the medicine, the supply of the medicine without the measuring device, if:</span></p><p class=\"Tablea\"><span>(a) other means of accurately measuring the dose are readily available; and</span></p><p class=\"Tablea\"><span>(b) any graphical representation of the device (including associated wording) is removed from any label for the medicine; and</span></p><p class=\"Tablea\"><span>(c) there are no changes to the directions for use of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>KMO</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a prescription medicine (other than a biological medicine) and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—prescription medicines other than biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the container or closure system used to store a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the synthesis of an active pharmaceutical ingredient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not a synthetic polypeptide; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(c) the European Directorate for the Quality of Medicines and Healthcare has reviewed the change; and</span></p><p class=\"Tablea\"><span>(d) the Directorate:</span></p><p class=\"Tablei\"><span>(i) has issued a revised certificate of suitability in relation to the ingredient; or</span></p><p class=\"Tablei\"><span>(ii) has declared that the ingredient does not require a revised certificate of suitability</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ACEP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient, or a non</span><span>‑</span><span>sterile intermediate of such an ingredient, of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture of an active pharmaceutical ingredient of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of an active pharmaceutical ingredient, or an intermediate of such an ingredient, of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with such a test in relation to the manufacture of the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If an active pharmaceutical ingredient of the medicine is manufactured by multi</span><span>‑</span><span>step synthesis involving one or more intermediates of the ingredient (including one or more intermediates prepared wholly or partly by fermentation):</span></p><p class=\"Tablea\"><span>(a) the transfer of the manufacture of such an intermediate to a different manufacturing site; or</span></p><p class=\"Tablea\"><span>(b) the manufacture of such an intermediate at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMF</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The transfer of the manufacture of a non</span><span>‑</span><span>sterile active pharmaceutical ingredient of the medicine to a different site, or the manufacture of such an ingredient at an additional site, if:</span></p><p class=\"Tablea\"><span>(a) the ingredient is not prepared by fermentation; and</span></p><p class=\"Tablea\"><span>(b) the ingredient is a pure chemical entity; and</span></p><p class=\"Tablea\"><span>(c) the ingredient is prepared:</span></p><p class=\"Tablei\"><span>(i) by chemical synthesis; or</span></p><p class=\"Tablei\"><span>(ii) through isolation from a natural source</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMTA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used for assaying or residual solvent testing (including testing for water) any of the following:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a shortening of the re</span><span>‑</span><span>test period for an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tablea\"><span>(b) the application of more restrictive storage conditions in relation to an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to an identification test used in relation to:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient;</span></p><p class=\"Tabletext\"><span>if the change makes a limit associated with a test for the ingredient, starting material or intermediate more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the addition of a new test and its associated limits, to the specifications for:</span></p><p class=\"Tablea\"><span>(a) an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) the starting materials for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine created in the synthesis of the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an active pharmaceutical ingredient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size of a manufacturing batch of the dosage form of the medicine if the dosage form is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMBS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) semi</span><span>‑</span><span>solid or liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) nasal or oral inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMEO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMES</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction, revision or discontinuation of:</span></p><p class=\"Tablea\"><span>(a) an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a limit associated with an in</span><span>‑</span><span>process control test applied during the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction or removal of an overage for an active pharmaceutical ingredient of, or excipient (other than an antioxidant) in, the medicine if the dosage form of the medicine is not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMRO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the method or equipment used to manufacture the dosage form of the medicine if the dosage form is:</span></p><p class=\"Tablea\"><span>(a) sterile; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The cessation of the manufacture, or a step in the manufacture, of the medicine at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMDM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) if the dosage form of the medicine is sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site;</span></p><p class=\"Tablea\"><span>(b) if the dosage form of the medicine is not sterile:</span></p><p class=\"Tablei\"><span>(i) a change to the location of a site where the labelling and primary and secondary packaging of the medicine are performed; or</span></p><p class=\"Tablei\"><span>(ii) the performance of those things at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile semi</span><span>‑</span><span>solid or non</span><span>‑</span><span>sterile liquid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile oral, or non</span><span>‑</span><span>sterile nasal, inhalation; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSO</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile solid; and</span></p><p class=\"Tablea\"><span>(b) not a modified release dosage form;</span></p><p class=\"Tabletext\"><span>either of the following:</span></p><p class=\"Tablea\"><span>(c) a change to the location of a site where the medicine is manufactured;</span></p><p class=\"Tablea\"><span>(d) the manufacture of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following:</span></p><p class=\"Tablea\"><span>(a) a change to the location of a site where either of the following are performed in relation to the medicine:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply;</span></p><p class=\"Tablea\"><span>(b) the performance of either of the following in relation to the medicine at an additional site:</span></p><p class=\"Tablei\"><span>(i) quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing);</span></p><p class=\"Tablei\"><span>(ii) release for supply</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DMTR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a non</span><span>‑</span><span>biological method used to assay an active pharmaceutical ingredient of, or an excipient in, the medicine, if the medicine is not a radiopharmaceutical</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to one or more tests used to identify an active pharmaceutical ingredient of, or an excipient in, the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSID</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with a default standard if previously no default standard applied to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a limit associated with a test included in the specifications for the medicine if the change makes the limit more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The addition of a new test and limits associated with the test to the specifications for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A minor change to a method used to test physiochemical parameters of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to test the sterility of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DSST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If:</span></p><p class=\"Tablea\"><span>(a) the medicine is not administered by the parenteral, ophthalmic or intra</span><span>‑</span><span>tracheal route; and</span></p><p class=\"Tablea\"><span>(b) the source of an excipient in the medicine is Category IC ruminant tissue;</span></p><p class=\"Tabletext\"><span>any of the following:</span></p><p class=\"Tablea\"><span>(c) a change in the source of the excipient to a non</span><span>‑</span><span>animal source;</span></p><p class=\"Tablea\"><span>(d) a change in the manufacturing process of the excipient;</span></p><p class=\"Tablea\"><span>(e) a change to the location of a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used to assay an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>38</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with a default standard that applies to the excipient if previously no default standard applied to the excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESIP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing an excipient in the medicine if the change makes the limits applied to the test results more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change, resulting from the introduction of a new test and its associated limits, to the specifications for an excipient in the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for an excipient in the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ESPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the outer packaging, or a component of a container, of the medicine if the packaging or component does not touch the dosage form of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCCA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the size or shape of a container or closure system for the medicine if the medicine is non</span><span>‑</span><span>sterile</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCSS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following changes to the specifications for a container or closure system for the medicine:</span></p><p class=\"Tablea\"><span>(a) the inclusion of a new test;</span></p><p class=\"Tablea\"><span>(b) making a limit more stringent;</span></p><p class=\"Tablea\"><span>(c) the deletion of a test procedure;</span></p><p class=\"Tablea\"><span>(d) a minor change to a test method</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CCST</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If the dosage form of the medicine is non</span><span>‑</span><span>sterile, and solid or semi</span><span>‑</span><span>solid, a decrease in the thickness of aluminium foil, or laminate material in laminated aluminium foil, used in blister packs, strip packs or sachets containing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMDT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An increase in the thickness of material used in a container or closure system for the medicine if the medicine has a dosage form that is:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>sterile; and</span></p><p class=\"Tablea\"><span>(b) solid, semi</span><span>‑</span><span>solid, semi</span><span>‑</span><span>liquid or liquid</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>CMIT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>47</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the name of an excipient in the medicine (whether or not the name is required to be included in the label under an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine)</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAE</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine that relates to how the proportion of the medicine that consists of its active ingredient is expressed if the dosage form of the medicine is topical preparation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the term “hypotonic”, “hypertonic” or “isotonic” if the medicine is a large</span><span>‑</span><span>volume injection</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQHI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include the release rate of the medicine if the medicine is a transdermal patch</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LQRT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a </span><span style=\"font-family:Cambria, serif\">label for the medicine </span><span>to include a warning or cautionary statement that administering the medicine by an incorrect route or method may be hazardous</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWAH</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a warning or cautionary statement if:</span></p><p class=\"Tablea\"><span>(a) the Secretary, under subsection</span><span> </span><span>9D(2) of the Act, has varied the entry in the Register that relates to the medicine to add that warning or cautionary statement; and</span></p><p class=\"Tablea\"><span>(b) the Secretary, under subsection</span><span> </span><span>25AA(4) of the Act, has varied the product information that is approved in relation to the medicine under subsection</span><span> </span><span>25AA(1) of the Act to add that warning or cautionary statement</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LWSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a physicochemical test method used for testing an active pharmaceutical ingredient of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASPC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to:</span></p><p class=\"Tablea\"><span>(a) the manufacture of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(b) a starting material for the synthesis of an active pharmaceutical ingredient of the medicine; or</span></p><p class=\"Tablea\"><span>(c) an intermediate of an active pharmaceutical ingredient of the medicine;</span></p><p class=\"Tabletext\"><span>if the change does not affect any step taken to sterilise the ingredient or intermediate</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>AMMC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from side or rear panels if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine as a consequence of:</span></p><p class=\"Tablea\"><span>(a) a variation, under subsection</span><span> </span><span>9D(3) of the Act, of the entry in the Register that relates to the medicine; or</span></p><p class=\"Tablea\"><span>(b) a condition imposed, under subsection</span><span> </span><span>28(3) of the Act, on the listing or registration of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LOCI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that removes phrases indicating novelty, such as “New formulation” or “New appearance”</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include a QR code, if the link is:</span></p><p class=\"Tablea\"><span>(a) to a website owned by the person in relation to whom the medicine is included in the Register; and</span></p><p class=\"Tablea\"><span>(b) to information that is non</span><span>‑</span><span>promotional</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPQR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include information about a patient support program</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPPS</span></p></td></tr></tbody></table>\n```\n\n  (1) For the purposes of paragraph 9D(2C)(b) of the Act, a variation of an entry in the Register that relates to a biological medicine and is listed in the table in subregulation (2) is specified.\n  (2) For the purposes of paragraph 9D(2C)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 2 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 3 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biological medicines</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine if the change makes the limits associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the equipment used for quality control testing (including sterility, microbiological, chemical, physical and bacterial endotoxin or pyrogen testing) the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSQC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The release for supply of the medicine at an additional site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the purification process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the holding time for a drug substance of the medicine, or an intermediate created during the manufacture of such a drug substance, if the medicine is not plasma</span><span>‑</span><span>derived</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPHR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the manufacturer of a filter used in a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPFM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on a fermentation process for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPNC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the time required to culture and harvest the cell line for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>FPRP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A reduction in the column life of columns used in the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFCR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The introduction of more stringent internal controls on the plasma fractionation process in the manufacture of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PFSC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing a drug substance or excipient of the medicine if the change makes a limit associated with the testing more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISNL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for a drug substance or excipient of the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the drug substance or excipient; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the drug substance or excipient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to a method used for testing a drug substance or excipient of the medicine if:</span></p><p class=\"Tablea\"><span>(a) the change is to adopt a method in a default standard; and</span></p><p class=\"Tablea\"><span>(b) the test is not for viral safety</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ISAM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for testing the medicine to include a new test and any associated limits if the new test is part of a default standard</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSNT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>A change to the specifications for the medicine made for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the medicine; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSPT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>16</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A minor change to a physicochemical test method used for testing the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PMPL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The replacement of an in</span><span>‑</span><span>house reference standard with another if the protocol and acceptance criteria for establishing a replacement in</span><span>‑</span><span>house reference standard have been approved by the Therapeutic Goods Administration</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IRSR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine that deletes text from a side or rear panel if:</span></p><p class=\"Tablea\"><span>(a) the text is present elsewhere on the label for the medicine; and</span></p><p class=\"Tablea\"><span>(b) repetition of the information on the panel is not required by an order in force under subsection</span><span> </span><span>10(1) of the Act, or a condition imposed by or under section</span><span> </span><span>28 of the Act, that applies to the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or amend the name or address of the Australian sponsor or distributor of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change the sponsor’s or distributor’s logo or livery</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCL</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to remove graphics, pictures or diagrams, and any associated text, other than a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPDG</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include, remove or change a pictogram of the medicine or its dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPCP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include:</span></p><p class=\"Tablea\"><span>(a) simple instructions or information relating to the packaging of the medicine; or</span></p><p class=\"Tablea\"><span>(b) information describing a change in appearance of the dosage form</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPIA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a label for the medicine to include or remove text written on the outer protective pouches, or the overwraps, of the container or primary pack of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LPOP</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the drug substance of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ASRS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life of the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSLD</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of anti</span><span>‑</span><span>tamper packaging if the packaging material is not in contact with the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PPAT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>28</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>Either or both of the following changes to the manufacture of the medicine:</span></p><p class=\"Tablea\"><span>(a) removal of a temperature excursion;</span></p><p class=\"Tablea\"><span>(b) reduction in the time spent out of refrigeration or freezer storage</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSET</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a storage condition for the medicine</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PSAR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the name or contact details of an albumin manufacturer or supplier, if the site or process has not changed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>OAMS</span></p></td></tr></tbody></table>\n```\n\n  (2) For the purposes of paragraph 9D(3AC)(c) of the Act, the following conditions are specified in relation to a variation of an entry in the Register that is listed in column 1 of an item in the following table:\n    (b) the other conditions set out in the TGA notifications process guidance document in relation to the code listed in column 2 of the item are satisfied.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kinds of variations—biologicals</span></p></td></tr><tr style=\"height:31.8pt\"><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Variation</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Code</span></p></td></tr></thead><tbody><tr><td style=\"width:13.58%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:71.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the specifications of the biological for the purposes of ensuring that the specifications are consistent with:</span></p><p class=\"Tablea\"><span>(a) a default standard that applies to the biological; or</span></p><p class=\"Tablea\"><span>(b) an order in force under subsection</span><span> </span><span>10(1) of the Act that applies to the biological</span></p></td><td style=\"width:14.78%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>PT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the donor selection criteria for the starting materials for the biological to make the criteria more stringent</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>DS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to an infectious disease test kit used to test the starting materials for the biological if the change does not decrease the kit’s ability to detect an infectious disease</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>TK</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>4</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to a critical material used in the manufacture of the biological if:</span></p><p class=\"Tablea\"><span>(a) the critical parameters for the changed material are equivalent or of greater quality; and</span></p><p class=\"Tablea\"><span>(b) the material is not of human or animal origin; and</span></p><p class=\"Tablea\"><span>(c) the material is not an excipient; and</span></p><p class=\"Tablea\"><span>(d) in the case of critical material that is a container for the biological—the change is not a change to the composition of the material</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>SM</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to an in</span><span>‑</span><span>process control test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MI</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The removal of a product if the biological is a Class 2 biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The addition of a site at which secondary packaging or storage of the biological is performed</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MA</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>8</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the location of a site at which either or both of the following are performed in relation to the biological, or the addition of a site at which either or both of the following are performed in relation to the biological:</span></p><p class=\"Tablea\"><span>(a) quality control testing;</span></p><p class=\"Tablea\"><span>(b) infectious disease testing</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The cessation of the manufacture or a step in the manufacture of the biological at a manufacturing site</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>MR</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>The introduction of more stringent limits to a release test applied during the manufacture of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BS</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A reduction in the shelf life or shipping timeframe of the biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>BT</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>A change to the label or supporting documentation for the biological to:</span></p><p class=\"Tablea\"><span>(a) change the name, address or other contact details of the sponsor, manufacturer or distributor; or</span></p><p class=\"Tablea\"><span>(b) change the name of an active ingredient as a result of a change to the Australian Cell and Tissue Name for the ingredient</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>LC</span></p></td></tr><tr><td style=\"width:13.58%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:71.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt\"><p class=\"Tabletext\"><span>For an export only biological, a change to information included in the entry in the Register for the export only biological</span></p></td><td style=\"width:14.78%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>EX</span></p></td></tr></tbody></table>\n```\n\n  (1) A kind of request mentioned in any of the following definitions is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act:\n  (2) A request that is made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations is prescribed for the purposes of subparagraph 9D(7)(b)(ii) of the Act.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom therapeutic goods are registered or listed.\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the therapeutic goods relate or the person’s interest in the therapeutic goods and also agrees to transfer or assign the registration or listing of the therapeutic goods in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the therapeutic goods are registered or listed; and\n\n  (1) The person in whose name goods (other than medical devices) are entered in the part of the Register for listed goods must apply to the Secretary to transfer the entry for the goods:\n    (a) if the goods become subject to inclusion in the part of the Register for registered goods—to the part of the Register for registered goods; or\n    (b) if the goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act—to the part of the Register for biologicals.\n  (2) If goods (other than medical devices) that are included in the part of the Register for registered goods become subject to inclusion in the part of the Register for listed goods, the person in whose name the goods are entered in the Register may apply to the Secretary:\n  (3) If goods (other than medical devices) that are included in the part of the Register for registered goods are specified by the Secretary to be a biological under subsection 32A(2) of the Act, the person in whose name the goods are entered in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals.\n  (4) If goods that are included in the Register under Part 3‑2A of the Act cease to be a biological because of a determination made by the Secretary under subsection 32A(3) of the Act, the person in whose name the goods are included in the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for:\n  (5) The person in whose name goods are included in the Register under Chapter 4 of the Act as a kind of medical device may apply to the Secretary to transfer the entry for the goods to the part of the Register for registered goods or the part of the Register for listed goods if the goods cease to be a medical device because of a declaration under subsection 41BD(3) of the Act.\n  (6) The person in whose name goods are included in a part of the Register must apply to the Secretary to transfer the entry for the goods to the part of the Register for biologicals if the goods:\n    (a) if the Secretary notifies the person in whose name the goods are entered in the Register of a reasonable period within which the application must be made—within that period; or\n\n    (a) the ability of the person in whose name the goods are entered in the Register to provide the information necessary to support the transfer of the entry; and\n  (10) It is not an offence for the sponsor of goods to which subregulation (1), (3), (4) or (6) applies to import, export, supply or manufacture the goods as listed goods, registered goods, medical devices included in the Register under Chapter 4 of the Act or biologicals included in the Register under Part 3‑2A of the Act until the later of:\n  (11) An application under this regulation is taken to be an application for registration, listing or inclusion of the goods.\n\n  (1) A person in whose name therapeutic goods or grouped therapeutic goods are registered or listed may apply for the therapeutic goods to be assigned a different registration or listing number.\n    (b) must have with it written information in such detail as is reasonably necessary to allow the application to be properly considered; and\n    (a) were grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) were not grouped therapeutic goods when a registration or listing number was assigned, or last assigned, to the goods; and\n    (a) may assign to grouped therapeutic goods to which subregulation (5) applies another registration or listing number; and\n\n  The Secretary must give notice, in writing, to a person in whose name therapeutic goods, or kinds of therapeutic goods, are registered or listed if a registration or listing number is assigned to the goods under regulation 10C.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are medical devices and that are included in the Register under Chapter 4 of the Act are to be included in the part of the Register for medical devices.\n\n  (1) This regulation applies in relation to a person (the relevant person) in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the kind of medical device relates or the person’s interest in the kind of medical device and also agrees to transfer or assign the inclusion of the kind of medical device in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the kind of medical device is included in the Register under Chapter 4 of the Act; and\n    (b) must, within 3 months after the transfer or assignment, in a form or a manner approved by the Secretary, notify the Secretary in writing of the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the kind of device in the Register under Chapter 4 of the Act.\n\n  (1) This regulation applies in relation to a person in relation to whom a kind of medical device is included in the Register under Chapter 4 of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the kind of medical device, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the kind of device is included in the Register under Chapter 4 of the Act; and\n    (ii) make available to the person a new certificate of the inclusion of the kind of device in the Register under that Chapter.\n\n  For paragraph 9A(4)(a) of the Act, therapeutic goods, and classes of therapeutic goods, that are biologicals and that are included in the Register under Part 3‑2A of the Act are to be included in the part of the Register for biologicals.\n\n  (1) This regulation applies to a person (the relevant person) in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the death within 3 months after it occurred.\n  (3) If the relevant person becomes bankrupt, the trustee in bankruptcy (the notifying person) of the estate of the bankrupt:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the bankruptcy within 3 months after the relevant person became bankrupt.\n  (4) If the relevant person is a body corporate that is being wound up, the liquidator (the notifying person) of the body corporate:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the winding up within 3 months after the body corporate is wound up.\n  (5) If the relevant person transfers or assigns, in whole or in part, the business to which the biological relates or the person’s interest in the biological and also agrees to transfer or assign the inclusion of the biological in the Register, the person (the notifying person) to whom the business or interest is transferred or assigned:\n    (a) is taken to be the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n    (b) must notify the Secretary, in a form or a manner approved by the Secretary, of the transfer or assignment within 3 months after the transfer or assignment.\n  (6) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), the Secretary may, in writing, request the person to provide further information to the Secretary in relation to the event.\n  (7) If the notifying person notifies the Secretary of an event under paragraph (2)(b), (3)(b), (4)(b) or (5)(b), and the person also provides any further information requested by the Secretary under subregulation (6), the Secretary must:\n    (ii) make available to the person a certificate of the inclusion of the biological in the Register under Part 3‑2A of the Act.\n\n  (1) This regulation applies to a person in relation to whom a biological is included in the Register under Part 3‑2A of the Act.\n  (2) If the person changes his, her or its name or, being a corporation, amalgamates with another corporation under a name that is different from the name entered in the Register in relation to the biological, the person must, within 3 months after the change of name or amalgamation, notify the Secretary, in a form or a manner approved by the Secretary, of the person’s new name and the circumstance giving rise to it.\n  (3) The Secretary may, in writing, request the person to provide further information to the Secretary about the change of name.\n  (4) If the person notifies the Secretary under subregulation (2) of a new name, and the person also provides any further information requested by the Secretary under subregulation (3), the Secretary must:\n    (a) amend the Register by entering the new name as the name of the person in relation to whom the biological is included in the Register under Part 3‑2A of the Act; and\n\n  (1) A person in whose name a biological is included in the Register under Part 3‑2A of the Act may apply for the biological to be assigned a different biological number.\n\n  The Secretary must give notice, in writing, to a person in whose name a biological is included in the Register under Part 3‑2A of the Act if a biological number is assigned to the biological under regulation 10I.\n\n  (3) Unless the contrary intention appears, an expression used in both this Part and the Minamata Convention has the same meaning in this Part as in that Convention.\n\n#### 10JB Importation of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless approved by the Secretary before importation\n\n  For the purposes of paragraph 9K(1)(a) of the Act, the importation into Australia of a therapeutic good that is mercury from a non‑party to the Minamata Convention is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the importation before the mercury is imported.\n\n  For the purposes of paragraph 9K(1)(b) of the Act, the export from Australia of a therapeutic good that is mercury is prohibited unless the Secretary has, in accordance with Division 4, approved, in writing, the export before the mercury is exported.\n\n  (3) An application is taken not to have been made if the application does not comply with the requirements referred to in subregulation (2).\n\n  The Secretary may approve an application under paragraph 10JD(1)(a) to import a therapeutic good that is mercury from a non‑party (the exporting party) to the Minamata Convention only if the Secretary is satisfied that:\n    (ii) a general notification of consent is in force for Australia in accordance with paragraph 7 of Article 3 of the Minamata Convention; and\n    (b) the exporting party has provided written certification that the mercury is neither sourced from primary mercury mining nor excess mercury from the decommissioning of chlor‑alkali facilities.\n\n  (1) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a Party (the importing Party) to the Minamata Convention only if the Secretary is satisfied that :\n  (2) The Secretary may approve an application under paragraph 10JD(1)(b) to export a therapeutic good that is mercury to a non‑party (the importing party) to the Minamata Convention only if the Secretary is satisfied that the importing party has provided:\n    (iii) the mercury will be used only for a use allowed under the Minamata Convention to a Party to the Minamata Convention or for environmentally sound interim storage as set out in Article 10 of the Minamata Convention.\n\n  For the purposes of subsection 9K(1) of the Act, the importation into, export from and manufacture in, Australia of therapeutic goods that are mercury‑added products is prohibited.\n\n  For the purposes of subsection 9K(3) of the Act, the manufacture in Australia of therapeutic goods that contain mercury‑added products is prohibited.\n\n    (a) an indication of the medicine is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is preliminary clinical data demonstrating that the medicine is likely to provide a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n    (d) the person who made the application under subsection 22C(1) of the Act has provided sufficient evidence of the person’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that provisional registration of the medicine would commence if the Secretary were to provisionally register the medicine.\n\n  For the purposes of subsection 22G(1) of the Act, a prescribed aspect of the quality of a medicine for oral ingestion is in vitro bioequivalence.\n\n  For the purposes of the definition of commercial quantity in subsection 3(1) of the Act, the commercial quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity of that kind of vaping goods specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Commercial quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Quantity</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of unit in subsection 3(1) of the Act, a unit of vaping goods means the quantity of the vaping goods specified in column 2 of an item in the following table for the kind of vaping goods specified in column 1 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Unit of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>400 ml</span></p></td></tr></tbody></table>\n```\n\n  For the purposes of the definition of permitted quantity in subsection 41QD(10) of the Act, the prescribed quantity of a kind of vaping goods specified in column 1 of an item in the following table is the quantity specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:81.04%; margin-left:56.7pt; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span></span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Kind of vaping goods</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Permitted quantity of vaping goods</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:53.32%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping device</span></p></td><td style=\"width:30.76%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping accessory</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:15.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:53.32%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Vaping substance that is a liquid</span></p></td><td style=\"width:30.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60 ml</span></p></td></tr></tbody></table>\n```\n\n    (ii) if the restriction on a restricted ingredient relates to its concentration in a relevant medicine—a different concentration of the restricted ingredient; or\n    (iii) if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine—different directions for use setting out a different recommended single or daily dose.\n    (b) for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:\n\n    (a) a Class 1 or Class 2 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (b) a Class 3 or Class 4 biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (c) an export only biological is separate and distinct from other biologicals if any of the following characteristics of the biological differ from other biologicals:\n    (a) the biological is separate and distinct from other biologicals under that subregulation by reason only of a difference in a characteristic mentioned in subparagraph (1)(a)(ii) or (1)(b)(iv); and\n    (b) the difference in that characteristic is the result of a request made under subsection 9D(3AA) of the Act to vary the entry of the biological in the Register.\n\n> principal manufacturer means the person who carries out the total manufacture of a product or, if more than one manufacturer is involved, the person who takes overall responsibility for the manufacture of the product, including releasing the product for supply.\n\n  (1) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in Schedule 5 are exempt from the operation of the following provisions of the Act:\n  (2) For subsections 18(1) and 32CA(2) of the Act, the therapeutic goods or classes of therapeutic goods mentioned in column 2 of an item in Schedule 5A are exempt from the operation of the following provisions of the Act:\n  (3) The exemptions mentioned in subregulation (2) are subject to compliance with the conditions mentioned in column 3 of an item in Schedule 5A for the therapeutic goods.\n  (4) If therapeutic goods to which this regulation applies cease to be exempt from the operation of Part 3‑2 or Division 4 of Part 3‑2A of the Act and the sponsor of the goods applied for registration, listing, or inclusion of the goods in the Register before the exemption ceased, this regulation is taken to apply to the goods until the application for registration, listing or inclusion in the Register is determined.\n\n  (1) For the purposes of subsection 18(1) of the Act, all medicines, other than medicines of a class or kind listed in Schedule 9 or 10 to the Poisons Standard, are exempted, subject to subregulation (2), from the operation of Part 3‑2 of the Act (except section 31A and sections 31C to 31F).\n  (1A) For the purposes of subsection 32CA(2) of the Act, and subject to subregulation (2), all biologicals are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption of a medicine under subregulation (1), or of a biological under subregulation (1A), is subject to compliance with the following conditions:\n    (ii) the person, or the guardian of the person, has given informed consent (as defined in subregulation (5)) to the medicine or biological being given to the person; and\n    (iii) a statement in relation to the person, in the form approved by the Secretary for the purposes of this subparagraph, is completed by the medical practitioner by whom, or at whose direction, the medicine or biological is given to the person or by a health practitioner acting on behalf of that medical practitioner; and\n    (b) the medicine or biological is dispensed on the prescription of a medical practitioner who has prescribed the medicine or biological in accordance with good medical practice.\n  (2A) An approval of a form referred to in subparagraph (2)(a)(iii) may require information to be given in accordance with specified software requirements:\n  (3) A person who completes a statement referred to in subparagraph (2)(a)(iii) in relation to a medicine or biological that is given to a person must send a copy of the statement to the Secretary within 28 days after the medicine or biological is given to the person.\n\n> Category A patient means a person who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.\n\n> informed consent, in relation to treatment or proposed treatment, means consent freely given by a person on the basis of information concerning the potential risks and benefits of the treatment that was sufficient information to allow the person to make an informed decision whether to consent to the treatment.\n\n  (1) For subsections 30G(2) and 32CG(2) of the Act, Schedule 5B sets out the requirements for an arrangement for disposal of unused emergency goods and unused emergency biologicals.\n    (a) the goods have become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (a) the biological has become (whether in relation to an indication for which the biological could have been used under the exemption or in relation to a different indication):\n\n  Without limiting the information that may be required by the Secretary under subsection 19(2) or 32CK(3) or (4) of the Act, that information may include, for therapeutic goods the subject of an application under subsection 19(1) or 32CK(1) of the Act for a use described in paragraph 19(1)(b) or 32CK (1)(e) of the Act:\n    (a) the names of the members of the ethics committee that has given approval for each proposed clinical trial of the goods and that will have responsibility for monitoring the conduct of each trial; and\n    (c) the name of the person who will be in charge of the trial site (or each trial site, if the trial is to be conducted at more than 1 site), unless that person is the principal investigator; and\n\n  (1) For subsections 19(1A) and 32CK(8) of the Act, this regulation specifies conditions attaching to an approval for the importation or supply of therapeutic goods for use solely for experimental purposes in humans.\n  (2) Before any clinical trials proposed to be undertaken in relation to the goods are started, the Secretary, must receive from the person to whom the approval is granted, and the principal investigator for each trial site:\n    (a) a written assurance that clinical trials will be conducted in accordance with the Guideline for Good Clinical Practice (the Practice Guideline), as in force from time to time, published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; and\n    (i) to comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and\n\n  (1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:\n    (c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and\n\n> Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.\n\n    (a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and\n\n  (3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1)(b), but must not impede the search.\n\n    (b) the use must comply with a procedural protocol approved by the ethics committee that has the function of monitoring the conduct of the trial at each trial site;\n    (c) the use must be in accordance with the ethical standards set out in the National Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council;\n    (d) the use must cease if the ethics committee mentioned in paragraph (b) informs the principal investigator that the use is inconsistent with:\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to medicines, medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (1A) For the purposes of subsection 19(6) of the Act, in relation to medicines, paragraph 19(6)(aa) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, in relation to the proposed supply of the medicines, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the medicines, to supply the medicines.\n  (1B) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n    (a) the medicine contains an active ingredient specified in column 2 of an item in the following table and does not contain any other active ingredient; and\n    (b) the medicine only contains the active ingredient in the strength and concentration (if any) specified in column 2 of that item; and\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:24.92%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:15.04%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.2%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:28.94%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Active ingredient</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens—multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intradermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>allergens – multiple, various (including control solutions)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>skin prick</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>confirmation of suspected allergic reactions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>amiloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypokalaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>argipressin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines; or</span></p><p class=\"Tablea\"><span>(b) treatment of uterine fibroids</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>betaxolol 0.25% (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of elevated intraocular pressure where other treatments are inappropriate</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bismuth subcitrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>buspirone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of generalised anxiety disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>calcitriol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of hypophosphatemic rickets in children; or</span></p><p class=\"Tabletext\"><span>treatment of hypoparathyroidism (with severe hypocalcaemia)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>carbidopa</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>premedication for F</span><span>‑</span><span>18 DOPA imaging</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>colecalciferol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of severe vitamin D deficiency and prevention of osteoporosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cinnarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders such as vertigo, tinnitus, nausea and vomiting (including Meniere’s disease).</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cream</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lotion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clobetasol propionate 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of dermatitis/eczema where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>clofazimine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Leprosy, granulomatous cheilitis, Melkersson Rosenthal Syndrome, confirmed </span><span style=\"font-style:italic\">mycobacterium avium</span><span> paratuberculosis in immunocompromised patients recommended by an infectious disease specialist, erythema nodosum leprosum, drug resistant tuberculosis, non</span><span>‑</span><span>tuberculosis mycobacterial infections or other infections as recommended by an infectious diseases specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>cyclopentolate, 0.2%, and phenylephrine, 1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>production of mydriasis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ciclosporin, 0.05%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops, emulsion</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of suppressed tear production due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye syndrome)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deflazacort</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of Duchenne muscular dystrophy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dehydrated ethanol (alcohol) 96% </span><span>‑</span><span> 100%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ampoule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progressive keratoconus and intra</span><span>‑</span><span>operative use in superficial keratectomy (single use per procedure)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dexamethasone (preservative free)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of inflammatory conditions of the eye that are non</span><span>‑</span><span>infected and steroid responsive in patients sensitive to preservative</span><span>‑</span><span>containing formulations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>diazoxide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of hypoglycaemia, hyperinsulinaemia, Beckwith</span><span>‑</span><span>Weiderman Syndrome or insulinoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>25</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>diflunisal</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of amyloidosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>dimethyl sulfoxide (DMSO)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>solution</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravesical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>symptomatic relief of interstitial cystitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>disulfiram</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>deterrent to alcohol consumption</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>doxycycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intralesional</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sclerotherapy of lymphatic malformations</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 DCFPyl (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 myocardial perfusion tracer (18F flurpiridaz)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>myocardial perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>F</span><span>‑</span><span>18 NaF (sodium fluoride)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>bone study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>famotidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention and management of hypersensitivity reactions to chemotherapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>flunarizine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of vestibular disorders or prophylactic treatment of migraine</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>furazolidone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) Galligas</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>aerosol</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung ventilation study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68</span><br><span>(Ga</span><span>‑</span><span>68) </span><span>‑</span><span> MAA</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lung perfusion study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Gallium</span><span>‑</span><span>68 prostate specific membrane antigen (PSMA)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) prostate cancer imaging study</span></p><p class=\"Tablea\"><span>(b) PET CT gallium</span><span>‑</span><span>68 PSMA whole body uptake study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>36A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ganciclovir</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>gel</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of cytomegalovirus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>37</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>glycopyrronium bromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of excessive salivation in patients with neurological conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>38</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>hyoscine hydrobromide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>patch</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>transdermal</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>treatment of excessive salivation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>39</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5 %</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>hypertonic sodium chloride, 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>temporary relief of corneal oedema (hypertonicity)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>40A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>iloprost</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of patients with severe disabling Raynaud’s phenomenon; or</span></p><p class=\"Tablea\"><span>(b) treatment of peripheral ischaemia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>41</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indigo carmine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative detection of suspected urethral injuries during abdominal and pelvic surgical procedures</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>indocyanine green dye</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intra</span><span>‑</span><span>operative diagnostic use</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42AA</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>interferon alpha</span><span>‑</span><span>2b</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ocular surface squamous neoplasia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>42A</span></p></td><td style=\"width:24.92%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ketotifen</span></p></td><td style=\"width:15.04%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of allergic conditions</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>43</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levofloxacin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection or drug resistant tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>44</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>levomepromazine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of nausea and vomiting or agitation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>45A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lifitegrast</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of dry eye disease</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) dotatate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of somatostatin receptor</span><span>‑</span><span>positive gastroenteropancreatic neuroendocrine tumors (GEP</span><span>‑</span><span>NETs)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>46B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><a id=\"_Hlk84511860\"><span>lutetium</span><span>‑</span><span>177 (Lu 177) prostate specific membrane antigen (PSMA)</span></a></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of metastatic castration</span><span>‑</span><span>resistant prostate cancer</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>48</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>syrup</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>49</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>50</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>melatonin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>lozenge</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of sleep disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>51A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>metolazone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of fluid overload</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>52</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>53</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>mexiletine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular arrhythmia or myotonic disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>54</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>moxifloxacin 0.5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory bacterial conjunctivitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>55</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nadolol</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of ventricular tachycardia or long QT Syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>56</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>natamycin 5%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory fungal blepharitis, conjunctivitis or keratitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>57</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>neomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sepsis prevention for colorectal operation</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nicotine in solution, salt or base form</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid or solid</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>inhalation</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>smoking cessation or management of nicotine dependence</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>immediate release tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>58B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nifedipine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of preterm labour; or</span></p><p class=\"Tablea\"><span>(b) treatment of pre</span><span>‑</span><span>eclampsia</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>59</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>60</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>nitazoxanide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of giardiasis, cryptosporidiosis or blastocystis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>61</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>paromomycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>antiprotozoal treatment of any of the following amoebic infections:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">blastocystis hominis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">dientomoeba fragilis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">entamoeba histolytica</span><span>;</span></p><p class=\"Tablea\"><span>(d) parasite infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>62</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pimozide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of schizophrenia, chronic psychosis or Tourette syndrome</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pristinamycin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of confirmed methicillin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">Staphylococcus aureus</span><span> or vancomycin</span><span>‑</span><span>resistant </span><span style=\"font-style:italic\">enterococci</span><span> infection where there is history of failed therapy with the other available antibiotics, at sites in relation to bone/joint/prosthesis; or</span></p><p class=\"Tabletext\"><span>treatment of refractory or resistant </span><span style=\"font-style:italic\">mycoplasma</span><span> </span><span style=\"font-style:italic\">genitalium</span><span> infections; or</span></p><p class=\"Tabletext\"><span>treatment of other infections as prescribed by an infectious disease specialist</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>subcutaneous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>63B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>progesterone in oil</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of progesterone deficiency</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>64</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>pyrazinamide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of tuberculosis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>65</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 20% dextran</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>66</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in 1.1% hydroxylpropyl methylcellulose (HPMC)</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>67</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>riboflavin, 0.1% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>68</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>riboflavin, 0.22% in sodium chloride</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>intraoperative use in corneal collagen crosslinking (CXL) procedures for the treatment of progressive keratoconus</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>69</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ripasudil 0.4%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>eye drops</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory corneal oedema or refractory glaucoma</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>70</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>sodium benzoate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of urea cycle disorders</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>71</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.03%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in children</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tacrolimus 0.1%</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ointment</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>topical</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment, or prolongation of flare</span><span>‑</span><span>free intervals, of moderate to severe atopic dermatitis/eczema in adults</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>72A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Technetium</span><span>‑</span><span>99m (99m Tc) prostate specific membrane antigen (PSMA)</span><span style=\"font-weight:bold\">‑</span><span>I&amp;S</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prostate cancer imaging study</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>75</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>76</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tetracycline</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of resistant </span><span style=\"font-style:italic\">Helicobacter Pylori</span><span> infection</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>77</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tick</span><span>‑</span><span>borne encephalitis vaccine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intramuscular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>prevention of tick</span><span>‑</span><span>borne encephalitis</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tinidazole</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of </span><span style=\"font-style:italic\">trichomonas vaginalis</span><span> infections of the genito</span><span>‑</span><span>urinary tract in female and male patients, giardiasis, amoebic dysentery or amoebic liver abscess; or</span></p><p class=\"Tabletext\"><span>treatment of acute giardiasis, acute amoebic dysentery or amoebic liver disease in children; or</span></p><p class=\"Tabletext\"><span>prevention of infection of the surgical site</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78A</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>78B</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tizanidine</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>tablet</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of spasticity where other treatments have failed</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>79</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>triamcinolone acetonide</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>suspension for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>ophthalmic</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of non</span><span>‑</span><span>infectious uveitis, visualisation during vitrectomy, diabetic macular oedema, cystoid macular oedema secondary to retinal vein occlusion, uveitic macular oedema or post</span><span>‑</span><span>operative macular oedema (cataract surgery)</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>80</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>verteporfin</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>powder for injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intravenous infusion</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>photosensitisation for photodynamic therapy</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>81</span></p></td><td style=\"width:24.92%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>yttrium</span><span>‑</span><span>90 (Y</span><span>‑</span><span>90) Citrate</span></p></td><td style=\"width:15.04%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>injection</span></p></td><td style=\"width:18.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>intraarticular</span></p></td><td style=\"width:28.94%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>radiosynovectomy treatment</span></p></td></tr></tbody></table>\n```\n\n  (1C) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of a medicine by the medical practitioner to a patient of that practitioner, where:\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr style=\"height:2.85pt\"><td colspan=\"5\" style=\"border-top:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Specified therapeutic goods</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p></td><td style=\"width:28.24%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p></td><td style=\"width:13.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p></td><td style=\"width:18.3%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 4</span></p></td><td style=\"width:27.26%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 5</span></p></td></tr><tr style=\"height:2.85pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Circumstances</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Dosage form</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Route of administration</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Indication</span></p></td></tr></thead><tbody><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment of autism spectrum disorder in adult patients; or</span></p><p class=\"Tablea\"><span>(e) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>spray</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol comprises 98% or more of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) any cannabinoids, other than cannabidiol, in the medicine are only those naturally found in cannabis and comprise 2% or less of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(d) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 60% or more and less than 98% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory anxiety in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>liquid</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) treatment of refractory chronic pain in adult patients; or</span></p><p class=\"Tablea\"><span>(b) treatment of refractory sleep disorders in adult patients; or</span></p><p class=\"Tablea\"><span>(c) treatment and management of refractory cancer pain in adult patients</span></p></td></tr><tr style=\"height:1pt\"><td style=\"width:12.9%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:28.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) cannabidiol derived from cannabis comprises 40% or more and less than 60% of the total cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(b) other cannabinoids (including tetrahydrocannabinol) derived from cannabis comprise the remaining cannabinoid content of the medicine; and</span></p><p class=\"Tablea\"><span>(c) the medicine contains no other active ingredients</span></p></td><td style=\"width:13.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>capsule</span></p></td><td style=\"width:18.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>oral</span></p></td><td style=\"width:27.26%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>treatment of refractory chronic pain in adult patients</span></p></td></tr></tbody></table>\n```\n\n  (2) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is suffering from a life‑threatening, or otherwise serious, illness or condition.\n  (3) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which a medicine, or a class of medicines, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the medicine or class of medicines complies with the treatment directions (if any) mentioned in the authority for the medicine or class of medicine.\n  (5) For the purposes of paragraph 19(7B)(b) of the Act, rules made under subsection 19(7A) of the Act must not specify a medicine or a class of medicines if the medicine, or a medicine included in the class, contains a substance of a kind covered by an entry in Schedule 8, 9 or 10 to the Poisons Standard.\n  (6) For the purposes of paragraph 19(7D)(b) of the Act, the information that must be contained in a notification under subsection 19(7C) of the Act in relation to the supply by a health practitioner of a medicine to a person is as follows:\n    (f) if the release mechanism of the medicine was clinically relevant to the supply of the medicine—information about the release mechanism;\n    (g) if the route of administration of the medicine was clinically relevant to the supply of the medicine—information about the route of administration;\n\n  (1) For the purposes of paragraph 19(6)(a) of the Act, in relation to therapeutic vaping substances that are not medicines (authorised vaping substances), medical practitioners engaged in clinical practice in or outside a hospital are a prescribed class of medical practitioners.\n  (2) For the purposes of subsection 19(6) of the Act, paragraph 19(6)(aa) of the Act does not apply if the supply is of an authorised vaping substance by a medical practitioner to a patient of that practitioner, where:\n  (3) The class of recipients prescribed for the purposes of paragraph 19(6)(b) of the Act is the class of recipients consisting of persons each of whom is seeking treatment for smoking cessation or the management of nicotine dependence.\n  (4) For the purposes of subsection 19(7) of the Act, the prescribed circumstances in which an authorised vaping substance, or a class of authorised vaping substances, may be supplied in accordance with an authority under subsection 19(5) of the Act are that the supplier of the authorised vaping substance or class of authorised vaping substances complies with the treatment directions (if any) mentioned in the authority for the authorised vaping substance or class of authorised vaping substances.\n\n  (1) For paragraph 32CM(4)(a) of the Act, the class of medical practitioners engaged in clinical practice in or outside a hospital is prescribed.\n  (2) For subsection 32CM(4) of the Act, paragraph 32CM(4)(b) does not apply to a medical practitioner engaged in clinical practice outside a hospital if the medical practitioner:\n    (a) has demonstrated that, for the proposed supply of the biological, the medical practitioner does not have access to an ethics committee that could approve the supply; and\n    (b) has received an endorsement, from a specialist college with established expertise relevant to the use of the biological, to supply the biological.\n  (3) For subsection 32CM(5) of the Act, the class of recipients each of whom is suffering from a life‑threatening, or serious, illness or condition is prescribed.\n  (4) For subsection 32CM(6) of the Act, the circumstances are that the supplier of the biological complies with any treatment directions mentioned in the authority for the biological.\n  (5) For the purposes of paragraph 32CM(7D)(b) of the Act, the information that must be contained in a notification under subsection 32CM(7C) of the Act in relation to the supply by a health practitioner of a biological to a person is as follows:\n\n  (1) For the purposes of paragraphs 19D(3)(c) and (4)(c) of the Act, the registration number or listing number of therapeutic goods is to be set out on the label of the goods in the following manner:\n    (b) in the case of medicines—by writing the number on the label on the container of the medicines, or, if the container is enclosed in a primary pack for supply, on the label on that primary pack; and\n    (c) subject to subregulation (2), in each case—by writing the number on the main label, or on a securely affixed sticker adjacent to the main label, immediately preceded by:\n  (2) If the Secretary is satisfied that compliance with paragraph (1)(c) in a particular case is not practicable, he or she may give a direction in writing that states an alternative manner in which the relevant number, immediately preceded by the appropriate letters stated in subparagraphs (1)(c)(i), (ii) or (iii), is to be set out, and in that case the number and letters are to be set out in accordance with the direction.\n\n    (a) a primary registry that at any time is in the World Health Organisation’s International Clinical Trials Registry Platform, as the registry exists from time to time;\n\n  For the purposes of paragraphs 28(5)(ca) and (e) of the Act, a person in relation to whom a medicine is registered or listed must comply with the record‑keeping requirements (if any) and the reporting requirements (if any) set out in the document published by the Therapeutic Goods Administration titled Pharmacovigilance Responsibilities of Medicine Sponsors, as in force from time to time.\n\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual registration charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual registration charge in respect of the goods for a financial year.\n    (b) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual listing charge in respect of the goods for a financial year, based on low value turnover of the goods;\n    (c) matters relating to an application to the Secretary under regulation 43AAH to waive the annual listing charge in respect of the goods for a financial year.\n    (a) matters relating to the scheme provided in Subdivision 2 of Division 1 of Part 7 of these Regulations for exempting a person from liability to pay an annual charge for inclusion of the biological in the Register for a financial year, based on low value turnover of the biological;\n    (b) matters relating to an application to the Secretary under regulation 43AAH to waive the annual charge for inclusion of the biological in the Register for a financial year.\n\n  For paragraphs 32DQ(1)(c) and (2)(c) of the Act and item 13 of the table in Schedule 5A to these Regulations, the period is as follows:\n    (a) if the information relates to an event or occurrence that represents a serious threat to public health—within 48 hours after the person first becomes aware of the event or occurrence;\n    (b) if the information relates to an event or occurrence that led to the death, or serious deterioration in the state of health of a patient, a user of the relevant biological or other goods or another person—within 10 days after the person first becomes aware of the event or occurrence;\n    (c) if the information relates to an event or occurrence that, if it occurred again, might lead to the death, or serious deterioration in the state of health, of a patient, a user of the relevant biological or other goods or another person—within 30 days after the person first becomes aware of the event or occurrence.\n\n  (1) In this Part, working day means a day that is not a Saturday, a Sunday or a day that is a holiday for Commonwealth offices in the Australian Capital Territory.\n  (2) The following periods are to be disregarded in calculating, for the purposes of a provision of this Part, the number of working days taken to perform the action that the provision requires to be performed:\n    (a) the period commencing on the day on which the Secretary sends a query, or a request for information, to an applicant or sponsor and ending either:\n    (i) at the end of the day on which the Secretary receives from the applicant or sponsor a complete response to the query or request; or\n    (A) at the end of the last day in the period specified in the notice given by the Secretary under subsection 31(1) of the Act; or\n    (B) if the applicant or sponsor and the Secretary agree in writing on another day for the purposes of this sub‑subparagraph—that day.\n    (b) the period commencing on the day of lodgment of an appeal concerning the application for which the action is required to be performed and ending at the end of the day on which the appeal is finally disposed of; and\n\n    (a) made under section 23 of the Act for the registration of a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application has passed preliminary assessment.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, if section 25 of the Act requires an evaluation in relation to the application, the evaluation must be completed within the period of:\n    (b) if the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation 16DA(2) is not satisfied—175 working days; or\n  beginning on the day the Secretary sends the notification that states that the application has passed preliminary assessment.\n\n    (a) made under subsection 9D(3) of the Act to vary information included in an entry in the Register that relates to a medicine that is a product of a kind specified in Part 1 of Schedule 10 to these Regulations; and\n  (2) The Secretary must, within 40 working days from the day of receipt of the application, send a notification in writing to the applicant that states whether the application is effective.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, if the application is effective, the application must be decided, and the applicant must be given notification of the decision, within the period of:\n    (a) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulations 16DA(1) and (2) are satisfied—120 working days; or\n    (b) if, in respect of the evaluation in relation to the application, the conditions mentioned in subregulation 16DA(1) are satisfied, but a condition mentioned in subregulation16DA(2) is not satisfied—175 working days; or\n\n    (a) the evaluation relates to a medicine (the evaluation medicine) that is the same as a medicine (an acceptable foreign approved medicine) that has been approved by a competent regulatory authority, of a foreign country or foreign jurisdiction determined under subregulation (3), for general marketing in that country or jurisdiction;\n    (c) the indications of the evaluation medicine are equivalent to the indications of the acceptable foreign approved medicine;\n    (d) the strength, dosage form, formulation and directions for use of the evaluation medicine are identical to those of the acceptable foreign approved medicine;\n    (e) the manufacturer and manufacturing process for the evaluation medicine are identical to those for the acceptable foreign approved medicine;\n    (f) an application for marketing approval for the evaluation medicine has not been delayed, deferred, rejected, refused or withdrawn in any country;\n    (ii) the reference product used by the competent regulatory authority mentioned in paragraph (a) to assess the bioequivalence of the acceptable foreign approved medicine (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (h) if the evaluation medicine is a biosimilar in relation to a registered medicine—the reference product used by the competent regulatory authority mentioned in paragraph (a) (in assessing the application for the approval for the acceptable foreign approved medicine) is identical to the registered medicine;\n    (i) the applicant in relation to the evaluation has given the Secretary the assessment, by the competent regulatory authority mentioned in paragraph (a), of the application for the approval for the acceptable foreign approved medicine;\n    (iii) includes comprehensive details of studies assessed in connection with the application for the approval for the acceptable foreign approved medicine; and\n    (iv) includes copies of any correspondence relating to the application for the approval for the acceptable foreign approved medicine between the competent regulatory authority and the applicant for the approval; and\n    (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).\n    (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;\n    (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;\n    (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;\n  (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.\n\n  The failure to decide, within the period specified in subregulation 16D(3), an application to which regulation 16D applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) Subject to subregulation (2), this regulation applies to an application, in relation to a medicine included in the Register that is a product of a kind specified in Part 1 of Schedule 10, to vary the information in the Register concerning the medicine in relation to:\n    (b) applies for a variation of therapeutic goods that will make the therapeutic goods as varied separate and distinct therapeutic goods because of subsection 16(1) of the Act.\n  within the period of 45 working days that commences on the day on which the application is lodged and the evaluation fee for the application is paid or, if lodgment and payment occur on different days, on the later of those days.\n  (4) If the Secretary raises an objection concerning an application to which this regulation applies, he or she must decide the application and notify the applicant of the decision within the period of 30 working days that commences on the day on which the Secretary receives the applicant’s response to the objection.\n  (5) If the Secretary does not comply with subregulation (3) and, if applicable, subregulation (4) in the case of an application to which this regulation applies, the Secretary is taken to have approved the application.\n\n  (1) Subject to subregulation (2), this regulation applies to an application to register a medicine that is a product of a kind specified in Part 1 of Schedule 10 if:\n    (c) the sponsor of the application holds a registration for a medicine that contains the same active ingredient or active ingredients, in the same dosage form and strength as stated in the application.\n  (2) This regulation does not apply to an application that, in the opinion of the Secretary, needs to be supported by clinical, pre‑clinical or bio‑equivalence data.\n  (3) The provisions of subregulations 16F(3), (4) and (5) apply to applications to which this regulation applies as if those applications were applications to which regulation 16F applies.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person concerning the following substances:\n    (a) a substance that is not an ingredient in listed goods or registered goods for supply in Australia, but that may be an ingredient in goods for which an application may be made for entry in the Register as listed goods or registered goods for supply in Australia;\n    (b) a new excipient in therapeutic goods for dermal application, being a substance not in use as an ingredient in any other listed goods or registered goods for supply in Australia at the time of conditional listing or conditional registration of those goods under section 28 of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(1), (2) or (3) or section 23 of the Act is not current.\n  (3) No fee is payable for an evaluation under paragraph (1)(b) if the evaluation is in respect of a new excipient introduced for use as an ingredient, in compliance with a condition under section 28 of the Act, imposed before the commencement of this regulation but not earlier than 6 months before the application for evaluation is made.\n\n#### 16GC Notification of preliminary assessment of applications and periods within which certain evaluations must be made\n\n  (1) This regulation applies to an application under section 32DD of the Act that requires an evaluation of a Class 2, Class 3 or Class 4 biological under section 32DE of the Act.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application has passed preliminary assessment within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(da) of the Act, the evaluation must be completed within 255 working days after the Secretary sends a notification to the applicant under subregulation (2).\n\n  (1) This regulation applies to an application (other than an application to which regulation 16GF applies) for an evaluation of a biological if the application requests the Secretary under subsection 9D(3A) or (3AA) of the Act to vary the entry of the Class 2, Class 3 or Class 4 biological in the Register.\n  (2) For the purposes of paragraph 63(2)(de) of the Act, the Secretary must send a notification in writing to the applicant that states whether the application is effective within 30 working days after the Secretary receives the application.\n  (3) For the purposes of paragraph 63(2)(df) of the Act, the application must be decided, and notification given to the applicant, within 255 working days after the Secretary sends a notification to the applicant under subregulation (2) that the application is effective.\n\n  The failure to decide, within the time mentioned in subregulation 16GD(3), an application to which regulation 16GD applies does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  (1) At the request of a person, and on payment of the prescribed fee, the Department may evaluate data submitted by the person about the following substances:\n    (a) a substance that is not an ingredient in a biological for supply in Australia, but that may be an ingredient in a biological for which an application may be made for inclusion in the Register under Part 3‑2A of the Act as a biological for supply in Australia;\n    (b) a new excipient in a biological, being a substance not in use as an ingredient in any other biological for supply in Australia at the time of inclusion in the Register under Part 3‑2A of the Act.\n  (2) An evaluation under this regulation may be made, although an application under subsection 9D(3A) or (3AA) or section 32DD of the Act is not current.\n\n#### 16GG Variation of certain entries in the Register—notification of effective requests and period within which decisions must be made\n\n  (1) For the purposes of paragraph 63(2)(df) of the Act, if the Secretary receives an RCMC1 (section 9D) request, a decision on the request must be made within 20 working days after the Secretary receives the application.\n    (a) the Secretary must notify the person making the request in writing as to whether the request is effective within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the request is effective—a decision on the request must be made within the period specified, for the purposes of paragraph 63(2)(df) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of effective requests and period within which decisions must be made</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of effective requests</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on request</span></p></td></tr></thead><tbody><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the request</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr><tr><td style=\"width:7.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:23.2%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:27.5%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:41.62%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the request has been accepted</span></p></td></tr></tbody></table>\n```\n\n  (3) A failure to make a decision on a request mentioned in this regulation within the period mentioned in this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GH Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which evaluations must be completed\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—the evaluation of the medicine to which the application relates must be completed within the period specified, for the purposes of paragraphs 63(2)(da) and (daaaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of application and period within which evaluations must be completed</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Completion of evaluation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.44%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.68%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)1 application</span></p></td><td style=\"width:26.52%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 60 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3A</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 30 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3B</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM1 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 45 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM2 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 90 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM3 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 150 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM4 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 180 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCM5 application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 210 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 20 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 64 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 120 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr><tr><td style=\"width:7.44%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:20.68%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:26.52%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.36%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 170 working days after the Secretary notifies the applicant that the application has passed preliminary assessment</span></p></td></tr></tbody></table>\n```\n\n  (2) A failure to complete an evaluation of an application mentioned in column 1 of an item of the table in subregulation (1) within the period mentioned in column 3 of the item does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n#### 16GI Registration and listing of certain medicines—notification of preliminary assessment of applications and period within which decisions on recommendations must be made\n\n    (a) the Secretary must notify the applicant in writing as to whether the application has passed preliminary assessment within the period specified, for the purposes of paragraph 63(2)(de) of the Act, in column 2 of the item; and\n    (b) if the application passes preliminary assessment—subject to subregulation (1A), a decision on whether to make a recommendation on the application must be made within the period specified, for the purposes of paragraph 63(2)(daaa) of the Act, in column 3 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Notification of preliminary assessment of applications and period within which decisions on recommendations must be made</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Kind of application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Notification of preliminary assessment</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span></p><p class=\"TableHeading\"><span>Decision on recommendation</span></p></td></tr></thead><tbody><tr><td style=\"width:7.82%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:20.64%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN1 application</span></p></td><td style=\"width:26.3%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 70 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN2 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 120 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN3 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 150 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr><tr><td style=\"width:7.82%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:20.64%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>IN4 application</span></p></td><td style=\"width:26.3%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Within 40 working days after the Secretary receives the application</span></p></td><td style=\"width:45.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The period of 180 working days beginning on the later of the following days:</span></p><p class=\"Tablea\"><span>(a) the day the Secretary notifies the applicant that the application has passed preliminary assessment;</span></p><p class=\"Tablea\"><span>(b) the day the evaluation fee is paid for the application</span></p></td></tr></tbody></table>\n```\n\n    (a) an application (the current application) is made under subsection 26BD(1) of the Act in relation to an ingredient; and\n    (b) the Secretary gives a notice under subsection 26BD(5) of the Act to the applicant stating that the current application has passed preliminary assessment; and\n    (c) at the time the Secretary gives the notice, there is no determination in force under subsection 26BB(1) of the Act in relation to that ingredient; and\n    (d) at the time the Secretary gives the notice, there are one or more other applications (each of which is a related application) that:\n    (e) if the current application is an IN1 application—70 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (f) if the current application is an IN2 application—120 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (g) if the current application is an IN3 application—150 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application; or\n    (h) if the current application is an IN4 application—180 working days beginning on the later of the start day and the day the evaluation fee is paid for the current application.\n    (b) if a determination is made under subsection 26BB(1) of the Act in relation to the ingredient—the day on which that determination commences.\n  (1C) For the purposes of this regulation, an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.\n  (2) A failure to make a decision on whether to make a recommendation on an application within the period applicable under this regulation does not make the Commonwealth, the Secretary or a delegate of the Secretary liable to a person for loss, damage or injury, of any kind, that is caused by or arises out of the failure.\n\n  For the purposes of paragraph 26BDA(c) of the Act, the period is the period of 2 months beginning on the day that the applicant is notified of the amount of the evaluation fee and of the requirement for that fee to be paid.\n\n#### 16GJ Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications\n\n  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:\n\n  (1) On receiving an application under subregulation 16H(1) to designate a medicine as an orphan drug, the Secretary must:\n  (2) The Secretary may decide to designate the medicine as an orphan drug if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that:\n    (a) if the medicine is not a new dosage form medicine—all of the criteria specified in subregulation (3) are satisfied in relation to the medicine; or\n    (b) if the medicine is a new dosage form medicine—all of the criteria specified in subregulation (4) are satisfied in relation to the medicine.\n    (b) the indication is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition in a particular class of patients (the relevant patient class);\n    (c) it is not medically plausible that the medicine could effectively treat, prevent or diagnose the condition in another class of patients that is not covered by the relevant patient class;\n    (i) if the medicine is intended to treat the condition—the condition affects fewer than 5 in 10,000 individuals in Australia when the application is made;\n    (ii) if the medicine is intended to prevent or diagnose the condition—the medicine, if it were included in the Register, would not be likely to be supplied to more than 5 in 10,000 individuals in Australia during each year that it is included in the Register;\n    (iii) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (e) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n    (c) it is not likely to be financially viable for the sponsor to market the medicine in Australia unless each fee referred to in paragraph 45(12)(c) were waived in relation to the medicine;\n    (d) none of the following has refused to approve the medicine for the treatment, prevention or diagnosis of the condition for a reason relating to the medicine’s safety:\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—the medicine provides a significant benefit in relation to the efficacy or safety of the treatment, prevention or diagnosis of the condition, or a major contribution to patient care, compared to those goods.\n  (5) If the Secretary decides to designate the medicine as an orphan drug, the Secretary must, as soon as practicable after making the decision, publish a notice on the Department’s website stating the following:\n  (6) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (7) If the Secretary decides to refuse to make the designation, the notification must include the reasons for the decision.\n\n  (1) If a designation under regulation 16J of a medicine as an orphan drug is in force, the sponsor of the medicine may apply to the Secretary to extend the designation for a further 6 months.\n    (i) if the medicine is not a new dosage form medicine—the criteria specified in paragraphs 16J(3)(e) and (f) are satisfied in relation to the medicine; or\n    (ii) if the medicine is a new dosage form medicine—the criteria specified in paragraphs 16J(4)(d) and (e) are satisfied in relation to the medicine; and\n    (c) the Secretary is satisfied that, if the Secretary were to extend the designation, the sponsor would make an application in relation to the medicine under section 23 of the Act before the end of the extended designation.\n  (5) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (6) If the Secretary decides to refuse to extend the designation, the notification must include the reasons for the decision.\n\n    (i) if the designated orphan drug is a new dosage form medicine—the criteria specified in subregulation 16J(4) are no longer satisfied in relation to the designated orphan drug; or\n    (ii) if the designated orphan drug is not a new dosage form medicine—the criteria specified in subregulation 16J(3) are no longer satisfied in relation to the designated orphan drug.\n  (2) Subsection 33(3) of the Acts Interpretation Act 1901 does not apply in relation to a revocation of a designation under regulation 16J of a medicine as an orphan drug.\n\n  For the purposes of subsection 25AAA(1) of the Act, this Part makes provision for and in relation to the making of a therapeutic goods (priority applicant) determination in relation to a medicine.\n\n  (1) A person may apply to the Secretary for a therapeutic goods (priority applicant) determination in relation to a medicine.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n    (b) subject to paragraph 45(12)(d), the fee prescribed in item 1B of Part 2 of Schedule 9 for making the application has been paid.\n\n> Note: Paragraph 45(12)(d) provides that the Secretary must waive the fee for applying for a therapeutic goods (priority applicant) determination in certain circumstances.\n\n  (1) On receiving an application under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to a medicine, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the medicine:\n    (b) an indication of the medicine (the priority indication) is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: Paragraph 16(1)(e) of the Act provides that, for the purposes of Part 3‑2 of the Act, therapeutic goods (other than medicine of the kind to which subsection 16(1A) of the Act applies) are to be taken to be separate and distinct from other therapeutic goods if they have different indications.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16R(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 23 of the Act for the registration of the medicine that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n    (c) the priority applicant gives the Secretary written notice under subsection 24E(2) of the Act that the applicant wishes to treat the application as having been refused; or\n\n    (i) the priority applicant specified in the determination has not made an application under section 23 of the Act for the registration of the medicine; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16R(2) are no longer satisfied in relation to the medicine.\n\n  For the purposes of subsection 32DEA(1) of the Act, this Part makes provision for and in relation to the making of biologicals (priority applicant) determinations.\n\n  (1) A person may apply to the Secretary for a biologicals (priority applicant) determination in relation to a biological, other than a Class 1 biological or an export only biological.\n    (c) have with it written information in such detail as is reasonably necessary to allow the application to be properly considered.\n\n  (1) On receiving an application under subregulation 16V(1) for a biologicals (priority applicant) determination in relation to a biological, the Secretary must:\n  (2) The Secretary may make the determination if the Secretary is satisfied, having regard to any matter that the Secretary considers relevant, that all of the following criteria are satisfied in relation to the biological:\n    (i) for a Class 2 biological—an intended clinical use (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threating or seriously debilitating condition; or\n    (ii) for a Class 3 or Class 4 biological—a therapeutic indication (the priority indication) of the biological is the treatment, prevention or diagnosis of a life‑threatening or seriously debilitating condition;\n    (i) no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods); or\n    (ii) if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Register (except in the part of the Register for goods known as provisionally registered goods)—there is substantial evidence demonstrating that the biological provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods;\n\n> Note: For paragraph (a), see section 32AB of the Act and regulation 11A for when a biological is separate and distinct from other biologicals.\n\n  (4) As soon as practicable after making the decision, the Secretary must notify the applicant, in writing, of the decision.\n  (5) If the Secretary decides to refuse to make the determination, the notification must include the reasons for the decision.\n\n    (a) comes into force on the day on which the Secretary notifies the priority applicant in accordance with subregulation 16W(4); and\n  (2) If the priority applicant specified in the determination makes an application under section 32DD of the Act to include the biological in the Register that passes preliminary assessment before the end of the 6 month period beginning when the determination comes into force, the determination remains in force until:\n\n    (i) the priority applicant specified in the determination has not made an application under section 32DD of the Act to include the biological in the Register; or\n    (b) the Secretary is satisfied that the criteria specified in subregulation 16W(2) are no longer satisfied in relation to the biological.\n\n  (1) For the purposes of subsection 34(1) of the Act, the therapeutic goods specified in Schedule 7 are exempt from the operation of Part 3‑3 of the Act unless the goods are supplied as pharmaceutical benefits.\n    (b) before the day on which the goods cease to be exempt, each person who carries out a step in the manufacture of the goods applies for a licence authorising the person to carry out the step on premises referred to in the application;\n  the goods produced by those persons carrying out the steps on those premises are taken to be exempt from the operation of that Part until each application is determined.\n\n  For the purposes of subsection 34(2) of the Act, the persons specified in column 2 of an item in Schedule 8 are exempt from the operation of Part 3‑3 of the Act in relation to the manufacture, or the steps in the manufacture, of the therapeutic goods specified in column 3 of that item.\n\n  For the purposes of section 40 of the Act, it is a condition of each licence that the licence holder must give the Secretary, at the time of payment of the annual licensing charge in respect of the licence:\n    (a) if the Secretary so requests—details of therapeutic goods manufactured by or on behalf of the licence holder during the period of 12 months immediately preceding the date on which the payment of the charge is due; and\n    (b) the name, qualifications and details of the relevant experience of any person nominated by the licence holder as having control of:\n\n    (a) a copy of the licence and of any document issued by the Secretary imposing or amending the conditions applicable to that licence are to be displayed publicly at the premises specified in the licence;\n    (b) unless the contrary intention appears in the licence or in documents issued by the Secretary imposing or amending the conditions applicable to the licence, the licence holder must:\n    (A) the materials used in the manufacture of the goods, the supplier and quantities of the materials used and details of the tests performed on those materials; and\n    (B) the procedures and controls employed in the manufacture of the goods, including the results of tests carried out during the processing of the goods; and\n    (D) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the goods; and\n    (B) if it is not unreasonable in the circumstances—retain at those premises, for not less than 12 months after the expiry date of the goods or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods, a sample of each batch of the finished goods; and\n    (iii) retain those records at the licensed premises for at least 12 months after the expiry date of the goods to which they relate or, if there is no expiry date, for not less than 6 years after completion of manufacture of the goods; and\n    (iv) ensure that the persons nominated by the licence holder as having control of the production of the goods and of the quality control measures that are to be employed in the manufacture of the goods maintain that control.\n\n  If:\n    (a) an applicant for a licence to manufacture therapeutic goods nominates a person as having control of the production of goods or the quality control measures in respect of the manufacture of the goods; and\n  then it is a condition of the licence that the licence holder must inform the Secretary as soon as practicable of the name, qualifications and experience of that other person.\n\n  (2) If a person who is the holder of a licence becomes bankrupt, the trustee in bankruptcy of the estate of the bankrupt:\n    (b) must, not later than 3 months after the body corporate is wound up, notify the Secretary, in writing, of the winding up.\n    (d) that person must, not later than 3 months after the transfer, notify the Secretary that the person has, by reason of that agreement, become an applicant for the licence.\n    (b) being a corporation, amalgamates with another corporation under a name that is different from the name of the holder of the licence;\n  the person must give notice in writing to the Secretary of the new name of the person, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance.\n  (5) When a person notifies the Secretary of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the person must send to the Secretary sufficient documentary evidence to establish the matter asserted in the notification.\n  (6) When a person is taken to be the holder of a licence in accordance with this regulation, the Secretary may regard the person as an applicant for the licence and may deal with the notification referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b) as if it were an application for a licence.\n  (7) In spite of subregulation (6), a person who is regarded as an applicant for a licence because of the operation of that subsection may continue to manufacture therapeutic goods under the original licence until the application is determined.\n  (8) If, at any time, the Secretary becomes aware that he or she has not been informed in accordance with this regulation of an event referred to in paragraph (1)(b), (2)(b), (3)(b), (4)(d) or (4A)(a) or (b), the Secretary may cancel the licence to which the event relates.\n\n  (1) An APS employee in the Department is an analyst for the purposes of performing functions and duties, or exercising powers, under this Part, if the Secretary nominates the APS employee, in writing, under this subregulation.\n  (2) The Secretary may only nominate a person under subregulation (1) if the Secretary is satisfied that the person has appropriate qualifications, experience or knowledge to perform those functions and duties or exercise those powers.\n\n  (1) An analyst may select a sample of goods for testing under this regulation for the purpose of the administration of the Act, regulations made under the Act, or an instrument made under the Act or those regulations, including (but not limited to) testing for any the following purposes:\n    (c) monitoring or investigating compliance or non‑compliance with the Act, regulations made under the Act, or an instrument made under the Act or those regulations;\n    (d) supporting the enforcement of the Act, regulations made under the Act, or an instrument made under the Act or those regulations.\n\n> Note: An analyst, a person who conducts a test on a sample of goods under an arrangement under paragraph (b), a person assisting the analyst or other person, and a person with whom an arrangement is made under paragraph (b), are protected persons for the purposes of section 61A (immunity from civil actions) and section 62 (protection from criminal responsibility) of the Act: see regulation 46B and those sections of the Act.\n\n  (3) However if, after a sample of goods is selected for testing (whether or not the testing has commenced or an arrangement has been made under paragraph (2)(b)), an analyst decides it is no longer appropriate, possible or necessary for the sample to be tested:\n\n  (1) If a sample of goods is tested under regulation 25 (including as arranged under paragraph 25(2)(b)), an analyst must issue a certificate setting out:\n  (5) If the goods from which the sample was taken are registered, listed or included in the Register, an analyst must cause a copy of the certificate to be given to the person in relation to whom the goods are so registered, listed or included.\n    (a) proceedings for an offence against the Act (see subsection 3(7) of the Act) or a contravention of a civil penalty provision; or\n  a certificate issued under subregulation (1) of this regulation is prima facie evidence of the matters set out in the certificate.\n  (7) A document purporting to be a certificate issued under subregulation (1) or a copy of that certificate is, unless evidence to the contrary is adduced, taken to be such a certificate or copy and to have been duly given.\n\n    (a) the patient has been clinically assessed by the treating medical practitioner to require the biological urgently to treat a serious condition; and\n    (b) a biological that is included in the Register under Part 3‑2A of the Act and conforms with the applicable manufacturing requirements and standards is not available, or is not available within the time necessary for treatment to occur; and\n\n    (b) the sponsor of the nonconforming biological mentioned in paragraph 33A(c) receives from the treating medical practitioner a copy of a written statement of the following:\n    (iii) why the biological is nonconforming with standards applicable to the biological or was not manufactured in accordance with relevant manufacturing principles under section 36 of the Act; and\n    (c) the medical or scientific director of the sponsor’s facility from which the supply of the biological is to occur must give written approval for release of the biological; and\n    (e) the consent and the approval must be placed on the patient’s medical records and a copy must be given to the treating medical practitioner.\n    (c) any other information requested by the Secretary, including any information requested after submission of the notification.\n  (3) The Secretary must give the sponsor written acknowledgement of the receipt of the notification within 28 days after receiving the notification and any further information requested by the Secretary.\n\n  For each nonconforming biological released from a cell or tissue bank, the sponsor of the nonconforming biological must give to the Secretary:\n    (b) within 14 days after a request by the Secretary—information about the supply of the nonconforming biological and the circumstances surrounding the supply, including:\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may appoint, in writing, up to 20 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (c) the continued retention of a medical device or other therapeutic good in, or the removal of a medical device or other therapeutic good from, the Register;\n\n  (1) The Minister may appoint, in writing, up to 16 persons to the committee in accordance with subregulations (2) and (3).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulations (4) and (5); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n    (b) the safety and quality of ingredients that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act for a listed complementary medicine;\n    (c) any requirements that are, or are proposed to be, included in a determination under subsection 26BB(1) of the Act in relation to ingredients for a listed complementary medicine;\n    (f) the continued retention of a complementary medicine in, or the removal of a complementary medicine from, the Register;\n\n  (1) The minister may appoint, in writing, up to 8 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 12 persons to the committee in accordance with subregulations (1A) and (1B).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (2); and\n\n  (1) The committee’s functions are, at the request of the Minister or Secretary, to provide advice and to make recommendations to the Minister or Secretary about one or more of the following matters:\n\n  (1) The Minister may, in writing, appoint up to 10 persons to the committee in accordance with subregulations (1A), (1B) and (2).\n    (a) to the extent reasonably practicable, membership of the committee is to represent the widest possible range of fields mentioned in subregulation (3); and\n\n  (3) A member, other than a member mentioned in subregulation (4), must not be appointed for more than 3 consecutive terms.\n  (4) A member appointed to a committee before the commencement of this subregulation must not be appointed for more than 3 further consecutive terms.\n\n    (b) during any period, or during all periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.\n\n    (b) must act with as little formality and as quickly as this Division and a proper consideration of the issues before the committee allow; and\n    (f) must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or proposed to be given by the committee).\n\n  (1) The chair of a committee may give written notice to the committee, or to some members of the committee, directing the committee, or those members, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n\n  (2) If the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting.\n\n  (1) A decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.\n  (2) The member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (1) A member of a committee is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.\n  (2) A committee, with the approval of the Secretary, may establish subcommittees, consisting of members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.\n  (4) A member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.\n  (6) When a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.\n  (7) A member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by a committee to the Minister or the Secretary may be given to another expert advisory committee for the advice of that committee.\n  (11) A committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52B(3) of the Act in accordance with regulation 42ZCE.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52B(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of a subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n> nominated member means a member of the Committee nominated under subsection 52C(3) of the Act in accordance with regulation 42ZCU.\n\n  (3) Membership of the Committee must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned in subregulation (2).\n\n  (2) The term of an appointment of an appointed member is as specified in the instrument of appointment but must not be longer than 3 years.\n\n  (6) The Commonwealth, each State, the Australian Capital Territory and the Northern Territory may, by written notice given to the Minister, nominate a member (the temporary nominee) to temporarily replace an existing member nominated by the Commonwealth, the State or Territory:\n  (7) The temporary nominee becomes a member of the Committee, and the existing member stops being a member of the Committee:\n\n    (a) during a vacancy in the office of the Chair, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when the Chair is absent from duty or from Australia, or is, for any other reason, unable to perform the functions of the Chair.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n    (a) during a vacancy in the office of an appointed member, whether or not an appointment has previously been made to the office; or\n    (b) during any period, or during all periods, when an appointed member is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.\n\n> Note: Section 33A of the Acts interpretation Act 1901 sets out various matters about acting appointments, including how long a person can act in a vacant office.\n\n  (1) The Chair of the Committee may give written notice to the Committee directing the Committee to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.\n  (3) If the Chair of the Committee considers it appropriate and efficient in the circumstances, the Chair may direct the Committee to meet by video conference or teleconference or to meet out of session.\n    (a) must act with as little formality and as quickly as this Subdivision and a proper consideration of the issues before the Committee allow; and\n    (e) must comply with any directions given, in writing, to the Committee by the Minister or the Secretary about the Committee’s performance of its functions (other than a direction about advice given or proposed to be given by the Committee).\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, email, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n  (3) If the Chair is temporarily absent from a meeting, the member chosen by the Committee members present must preside at the meeting.\n\n  (1) A decision made at a Committee meeting by a majority of the votes of the members present and voting is a decision of the Committee.\n\n> Note: Decisions of the Committee relate to the recommendations and advice the Committee provides to the Secretary under subsection 52C(4) of the Act.\n\n  (2) The member presiding at a Committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.\n\n  (2) The Committee, with the approval of the Secretary, may establish subcommittees, consisting of Committee members and other persons.\n  (3) The function of the subcommittee is to inquire into, and report to the Committee on, any matter referred to the subcommittee that is within the functions of the Committee.\n  (4) A Committee member who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (5) The disclosure must be recorded in the minutes of the meeting and the member must not, unless the Committee otherwise determines, either be present during any deliberation of the Committee about the matter or take part in any decision of the Committee about the matter.\n  (6) When the Committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect material personal interest (whether pecuniary or not) in the matter to which the disclosure relates, must not be present during any deliberation of the Committee and must not take part in making the determination.\n  (7) A member of a subcommittee appointed by the Committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at a meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.\n  (8) Any advice or recommendation given by the Committee to the Secretary may be given to another committee established under the Act or these Regulations for the advice of that committee.\n  (10) Anything done by a person purporting to be, or purporting to act as, a Committee member (including the Chair) is not invalid because:\n  (11) The Committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.\n\n  For section 52CA of the Act, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling may hold joint meetings in accordance with this Division.\n\n  (1) The Secretary may, if the Secretary considers it appropriate to do so, give written notice to the Committee members of both Committees directing the Committees to hold a joint meeting at the time and place, and to deal with the matters in the manner, stated in the notice.\n  (2) At a joint meeting, the Committee members present at the meeting must vote on which Chair (or presiding member) is to be the Chair of the joint meeting.\n  (3) For the purpose of choosing a Chair, a Committee member may cast one vote in respect of each Committee of which he or she is a member.\n  (6) A decision made at a joint meeting is taken to be a decision of each Committee for the purposes of any advice or recommendation provided to the Secretary by either Committee.\n\n> Note: Decisions at a joint meeting relate to the recommendations and advice a Committee may provide to the Secretary under subsections 52B(4) and 52C(4) of the Act.\n\n> proposed amendment means a proposal to amend the current Poisons Standard under subsection 52D(2) of the Act on the Secretary’s own initiative or in response to an application under section 52EAA of the Act.\n\n  (1) For subsection 52D(2) of the Act, this Subdivision sets out the procedure that is to be followed in amending the current Poisons Standard:\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n    (d) inviting public submissions to be made to the committee by a date mentioned in the notice as the closing date for public submissions (the first closing date).\n\n  (1) At a meeting of an expert advisory committee to consider the proposed amendment, the committee must consider all public submissions received by the first closing date that:\n  (3) Subject to subregulation (4), the Secretary must publish, in a manner the Secretary considers appropriate, all public submissions received on or before the first closing date.\n\n  After consideration of any public submissions received, the expert advisory committee must provide advice or a recommendation to the Secretary in relation to the proposed amendment.\n\n  After considering the advice or recommendation of the expert advisory committee, the Secretary must, subject to regulation 42ZCZO, make an interim decision in relation to the proposed amendment.\n\n  (1) The Secretary may make a final decision without making an interim decision if no public submissions are received in response to an invitation under paragraph 42ZCZK(1)(d).\n\n  (1) As soon as practicable after making the interim decision, the Secretary must publish, in a manner the Secretary considers appropriate, a notice:\n    (b) if the interim decision is to amend the current Poisons Standard—specifying the proposed date of effect of the proposed amendment; and\n    (c) inviting interested persons to make submissions to the Secretary in relation to the interim decision by a date mentioned in the notice as the closing date for submissions (the second closing date); and\n    (d) if the interim decision is in response to an application made under section 52EAA—inviting the person who made the application to make a submission in relation to the interim decision by the second closing date.\n\n  (1) If the Secretary receives further submissions on or before the second closing date, the Secretary must, as soon as practicable after the second closing date:\n    (b) reconsider the interim decision in light of those submissions and any advice received in response to a request under paragraph (2)(a).\n  (4) Subject to subsection (5), the Secretary must publish, in a manner the Secretary considers appropriate, all relevant submissions.\n\n    (a) after considering all relevant submissions and any advice received in response to a request under paragraph 42ZCZQ(2)(a); or\n\n> Note: This Subdivision does not limit the way the Secretary may exercise a power under subsection 52D(2) of the Act in other circumstances.\n\n  (1) If the Secretary decides to amend the current Poisons Standard in the manner set out in the application, the Secretary may make a final decision without making an interim decision.\n\n  If the Secretary decides not to amend the current Poisons Standard in the manner set out in the application, the Secretary must:\n    (ii) advising the applicant that he or she may, within the period specified in the notice (not being less than 10 business days after the date of the notice), make a written submission to the Secretary about the interim decision.\n\n  If the Secretary makes an interim decision on the application, the Secretary may make a final decision on the application by confirming, varying or setting aside the interim decision only:\n    (a) after considering any submission provided by the applicant within the time specified in the notice under paragraph 42ZCZV(b); or\n\n  (1) For this Division (other than Subdivision 3) and subject to regulation 43AABB, a person’s turnover of therapeutic goods for a financial year is of low value if the turnover is $0.\n    (a) a person’s turnover of therapeutic goods for a financial year commencing on or after 1 July 2015 is the gross amount (in dollars) received (excluding GST) from sales (whether direct or indirect) of the goods in Australia by the person for the financial year; and\n    (b) a person’s turnover of therapeutic goods (other than a biological) for a financial year commencing before 1 July 2015 is the person’s turnover, as defined by regulation 43AAB of these Regulations as in force immediately before 1 July 2015, for the goods.\n\n  (1) For paragraph 44(1)(a) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable:\n    (a) if the person who is liable to pay the charge notifies the Secretary, under regulation 43AAF or 43AAGE, that the person’s turnover of the therapeutic goods concerned for the financial year will not be of low value—on the last day of the month commencing after the month in which the notification was given; or\n    (b) if the person who is liable to pay the charge does not give the Secretary a declaration relating to the person’s turnover of the therapeutic goods concerned for the financial year, in accordance with whichever of regulation 43AAC, 43AAD, 43AAGB or 43AAGC is applicable—on 15 September in the next financial year.\n  (2) For subparagraph 44(1)(b)(ii) of the Act, an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year becomes payable on 15 September in that year.\n\n> Note 1: A person is not liable to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register for a financial year if:\n\n> Note 2: This regulation is subject to subsection 44(3) of the Act. That subsection provides that the Secretary may, by notice in writing given to a person, specify a later day on which a charge becomes payable by the person for a financial year.\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom therapeutic goods (other than an IVD device) are registered, listed or included in the Register at any time in a financial year from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year, if the person’s turnover of the goods for the financial year is of low value.\n\n#### 43AABB Exemption from liability to pay certain annual charges—2014‑15 financial year—goods entered on Register on or after 1 May 2015 and on or before 30 June 2015\n\n  (1) This regulation applies in relation to therapeutic goods (other than a biological) that are registered, listed or included in the Register, if the registration, listing or inclusion commenced on or after 1 May 2015 and on or before 30 June 2015.\n  (2) The person in relation to whom the goods are registered, listed or included in the Register is taken to have been granted, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014, on the ground that the turnover of the goods for that financial year was a low value turnover.\n  (3) For this regulation, the following expressions have the meaning given by regulation 43AAB of these Regulations, as in force immediately before 1 July 2015:\n\n  (1) A person in relation to whom therapeutic goods (other than a biological) are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year if the requirements in subregulation (2), (3), (4), (5), (5A) or (5B) are met.\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 May 2015 and on or before 30 June 2015; and\n    (b) the person is taken, under regulation 43AABB, to have been granted an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the financial year commencing on 1 July 2014 (the 2014‑15 financial year); and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (a) the registration, listing or inclusion in the Register of the goods commenced on or after 1 July 2014 and on or before 30 April 2015; and\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for the 2014‑15 financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2014‑15 financial year was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (i) the person had been granted an exemption, under Subdivision 2 of Division 1 of Part 7 of these Regulations as in force immediately before 1 July 2015, from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for that financial year; or\n    (ii) before 1 July 2015, the Finance Minister, under paragraph 63(1)(a) of the Public Governance, Performance and Accountability Act 2013, authorised the waiver of an annual registration charge, an annual listing charge or an annual charge for inclusion in the Register in respect of the goods for that financial year; and\n    (d) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for each financial year referred to in paragraph (b) was of low value; and\n    (f) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or after 1 July 2014 and on or before 30 June 2015; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2014‑15 financial year was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n    (b) the inclusion in the Register of the joint replacement medical device as a Class III medical device commenced on or before 30 June 2014; and\n    (c) the medical device is covered by subregulation 11.22(3) of the Therapeutic Goods (Medical Devices) Regulations 2002; and\n    (d) the person’s turnover of the medical device for each financial year commencing on or after 1 July 2013 and ending on or before 30 June 2015 year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for each financial year referred to in paragraph (d) was of low value; and\n    (g) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the medical device for the 2015‑16 financial year was of low value.\n  (6) A person in relation to whom a biological is included in the Register at any time in the 2015‑16 financial year is exempt from liability to pay an annual charge for inclusion of the biological in the Register for the 2015‑16 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2016, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the 2015‑16 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2015‑16 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2015‑16 financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the 2015‑16 financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the 2015‑16 financial year.\n\n  A person in relation to whom therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) is exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the goods for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the goods for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAE.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAF.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the goods for the current financial year was not of low value, the Secretary may, under regulation 43AAG, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year commencing on or after 1 July 2015 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the goods in accordance with whichever of regulation 43AAC or 43AAD was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAC or 43AAD was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2015—a declaration in accordance with whichever of paragraph 43AAC(3)(d), (4)(d), (5)(d), (5A)(e) or (5B)(e) was applicable.\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2015—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) therapeutic goods that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the registration, listing or inclusion commenced in the current financial year;\n    (b) therapeutic goods (other than a biological) that are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2015 (the current financial year) if the person in relation to whom the goods are registered, listed or included in the Register was exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the immediately preceding financial year;\n    (c) a biological that is included in the Register at any time in a financial year commencing on or after 1 July 2016 (the current financial year) if the person in relation to whom the biological is included in the Register was exempt from liability to pay an annual charge for inclusion of the biological in the Register for the immediately preceding financial year.\n  (2) If the person in relation to whom the goods are registered, listed or included in the Register becomes aware during the current financial year that the person’s turnover of the goods for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the registration, listing or inclusion in the Register of the goods commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) therapeutic goods are registered, listed or included in the Register at any time in the financial year commencing on 1 July 2015 (the 2015‑16 financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAC or 43AAE, a declaration stating that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the 2015‑16 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the 2015‑16 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n    (a) therapeutic goods are registered, listed or included in the Register at any time in a financial year commencing on or after 1 July 2016 (the relevant financial year); and\n    (b) the person in relation to whom the goods are registered, listed or included in the Register has given the Secretary, in accordance with regulation 43AAD or 43AAE, a declaration stating that the person’s turnover of the goods for the relevant financial year was of low value; and\n    (c) the person has not paid an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the goods for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods:\n    (ii) for any later financial year for which the person did not pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of the goods (other than because the charge was waived under regulation 43AAH); and\n\n  For section 44A of the Act, this Subdivision makes provision for and in relation to exempting a person in relation to whom an IVD device is included in the Register at any time in a financial year from liability to pay an annual charge for inclusion in the Register in respect of the device for the financial year, if the person’s turnover of the device for the financial year is of low value.\n\n  (1) A person in relation to whom an IVD device is included in the Register at any time in the financial year commencing 1 July 2017 (the 2017‑18 financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (c) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n  (2) A person in relation to whom an IVD device is included in the Register on or before 30 June 2017 is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year if:\n    (b) the person’s turnover of the device for the financial year commencing on 1 July 2016 (the 2016‑17 financial year) is of low value; and\n    (c) the person gives the Secretary, on or before 22 July 2017, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2016‑17 financial year was of low value; and\n    (e) the person gives the Secretary, on or before 22 July 2018, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the 2017‑18 financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the 2017‑18 financial year only because the person did not give the Secretary the declaration, or declarations, relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the 2017‑18 financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the 2017‑18 financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device, for a financial year for which a declaration was given under this regulation, was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the 2017‑18 financial year.\n\n  A person in relation to whom an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the current financial year) is exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the current financial year if the following requirements are met:\n    (i) the person was exempt from liability to pay the charge in respect of the device for the immediately preceding financial year; or\n    (c) the person gives the Secretary, on or before 22 July of the next financial year, a declaration, in a form or a manner approved by the Secretary, stating that the person’s turnover of the device for the current financial year was of low value.\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n> Note 3: If a person is not exempt from liability to pay an annual charge for the current financial year only because the person did not give the Secretary the declaration relating to turnover in accordance with this regulation, the person may be exempt from liability to pay the charge for the current financial year under regulation 43AAGD.\n\n> Note 4: If a person becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary of that fact under regulation 43AAGE.\n\n> Note 5: If the Secretary becomes aware that a person’s turnover of the device for the current financial year was not of low value, the Secretary may, under regulation 43AAGF, notify the person that the person is liable to pay the charge for the current financial year.\n\n  (1) This regulation applies if a person would have been exempt from liability to pay an annual charge for inclusion in the Register in respect of an IVD device for a financial year commencing on or after 1 July 2017 (the relevant financial year), except that the person did not give the Secretary a declaration, or declarations, relating to the person’s turnover of the device in accordance with whichever of regulation 43AAGB or 43AAGC was applicable.\n    (a) a notice stating the reasons why the person was not able to give the Secretary the declaration, or declarations, in accordance with whichever of regulation 43AAGB or 43AAGC was applicable for the relevant financial year; and\n    (c) if the relevant financial year is the year commencing on 1 July 2017—a declaration in accordance with paragraph 43AAGB(2)(c).\n\n> Note: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) The person is exempt from liability to pay the charge for the relevant financial year if the person gives the Secretary, on or before 15 September in the next financial year:\n    (c) if the relevant financial year is the year commencing on 1 July 2017—the declaration referred to in paragraph (2)(c); and\n  (5) If the person is exempt from liability to pay the charge for the relevant financial year under subregulation (4), the Secretary must give the person a written notice stating that the person is exempt from liability to pay the charge for the relevant financial year.\n  (6) If the person gives the Secretary documents other than in accordance with subregulation (2), or the documents were not accompanied by the fee referred to in subregulation (3), the Secretary must give the person a written notice that:\n    (b) states the reason why the person is not exempt from liability to pay the charge for the relevant financial year, being whichever of the following is applicable in the circumstances:\n    (ii) one or more of the documents given was not in accordance with paragraph (2)(a) or (b) or, if applicable, paragraph (2)(c);\n\n    (a) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the inclusion commenced in the current financial year;\n    (b) an IVD device that is included in the Register at any time in a financial year commencing on or after 1 July 2017 (the current financial year) if the person in relation to whom the device is included in the Register was exempt from liability to pay an annual charge for inclusion in the Register in respect of the device for the immediately preceding financial year.\n  (2) If the person in relation to whom the device is included in the Register becomes aware during the current financial year that the person’s turnover of the device for that year will not be of low value, the person may notify the Secretary, in a form or a manner approved by the Secretary, of that fact.\n  (3) As soon as practicable after receiving a notification from a person under subregulation (2), the Secretary must give the person a written notice that specifies the date on which the charge for the current financial year becomes payable.\n\n> Note: If the inclusion in the Register of the device commenced in the current financial year, the date must be the last day of the month commencing after the month in which the notification under subregulation (2) was given (see paragraph 43AAB(1)(a)).\n\n    (a) an IVD device is included in the Register at any time in the financial year commencing on 1 July 2017 (the 2017‑18 financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGB or 43AAGD, a declaration stating that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year, was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the 2017‑18 financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the 2017‑18 financial year, or for a previous financial year for which a declaration was given, was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n    (a) an IVD device is included in the Register at any time in a financial year commencing on or after 1 July 2018 (the relevant financial year); and\n    (b) the person in relation to whom the device is included in the Register has given the Secretary, in accordance with regulation 43AAGC or 43AAGD, a declaration stating that the person’s turnover of the device for the relevant financial year was of low value; and\n    (c) the person has not paid an annual charge for inclusion in the Register in respect of the device for the relevant financial year; and\n    (d) the Secretary becomes aware that the person’s turnover of the device for the relevant financial year was not of low value;\n    (a) state that the person was not exempt from liability to pay an annual charge for inclusion in the Register in respect of the device:\n    (ii) for any later financial year for which the person did not pay an annual charge for inclusion in the Register in respect of the device (other than because the charge was waived under regulation 43AAH); and\n\n  For the purposes of paragraph 63(3)(b) of the Act, this Subdivision makes provision for and in relation to waiving an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year in certain circumstances.\n\n    (ii) a medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher; or\n    (iii) an IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher.\n  (3) An application under subregulation (2) in relation to particular therapeutic goods and a financial year (the relevant financial year) must:\n    (i) if the registration or inclusion in the Register of the goods commenced in the relevant financial year—before 31 December in the next financial year; and\n    (b) be accompanied by information in support of the application that addresses the matters referred to subregulations (7) and (8).\n\n> Note 2: A person may commit an offence if the person provides false or misleading information or documents (see sections 137.1 and 137.2 of the Criminal Code).\n\n  (4) Within 60 days after receiving an application in accordance with subregulation (3) to waive a charge for a financial year, the Secretary must decide:\n    (b) must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a request from the Secretary.\n  (6) Paragraph (5)(a) does not otherwise limit the information the Secretary may take into account in considering the application.\n    (a) the goods to which the charge relates are registered or included in the Register at the time the Secretary is considering the application; and\n    (c) it would not be financially viable for the entry in relation to the goods to remain on the Register if the person in relation to whom the goods are entered in the Register were required to pay the charge for that financial year.\n  (8) For the purpose of considering whether it is in the interest of public health for the entry in relation to the goods to which the charge relates to remain on the Register, the Secretary must take into account the following matters:\n    (b) the clinical needs of the population who use the goods and the reasonable availability of alternatives to the goods for that population;\n    (d) the likelihood of the goods being available through alternative means to the population who use the goods if the person in relation to whom the goods are entered in the Register were to request the Secretary to cancel the entry.\n  (9) The Secretary may take into account any other matter the Secretary considers relevant for the purpose of considering the matter referred to in subregulation (8).\n  (10) As soon as practicable after making a decision under subregulation (4), the Secretary must give written notice of the decision to the applicant.\n  (12) If the Secretary decides to waive the charge for the financial year, the decision has effect unless, before the end of the financial year, the person in relation to whom the goods concerned are entered in the Register requests the Secretary to cancel the entry in relation to the goods.\n  (13) If a decision by the Secretary to waive a charge for a financial year in respect of therapeutic goods ceases to have effect because the entry in relation to the goods in the Register is cancelled at the request of the person in relation to whom the goods were entered in the Register, the Secretary must give the person a written notice that specifies the date on which the charge for the financial year becomes payable.\n\n  (2) The annual charge payable by the person for a licence in force at any time during the financial year, other than a licence for the manufacture of human blood and blood components, is 50% of the amount otherwise payable under subsection 7(5) of the Therapeutic Goods (Charges) Regulations 2018 for the licence.\n\n    (a) the fee mentioned in column 3 of an item in Part 2 or 3 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 2 of the item; and\n    (aa) the fee mentioned in column 2 of an item in Part 4 of Schedule 9 is prescribed for the matter that, for that fee, is mentioned in column 1 of the item; and\n    (b) the fee mentioned in column 3 of an item in Part 2 of Schedule 9A is prescribed for the matter that, for that fee, is mentioned in column 2 of the item.\n  (2) If, but for this subregulation, more than one fee referred to in item 9 in Part 2 of Schedule 9 would otherwise apply in relation to:\n\n  (2) The applicable fee under item 2 or 3 in Part 2 of Schedule 9 for an application to transfer an entry of a kind of medical device from the part of the Register for medical devices to the part of the Register for registered goods, or the part of the Register for listed goods, is not payable if the device ceases to be a medical device because of a declaration in force under subsection 41BD(3) of the Act.\n  (4) The fee under paragraph (b) of item 3 of the table in Part 2 of Schedule 9 for an application for the listing of medicine is not payable if:\n    (b) the sponsor of the application holds a listing for medicine (the existing medicine) that is the same as the relisted medicine, disregarding differences in relation to indications; and\n    (c) the relisted medicine, if listed, would form part of the same gazetted therapeutic goods group as the existing medicine; and\n\n  If:\n    (a) an applicant has paid the whole of the evaluation fee payable under Part 2 of Schedule 9 for an evaluation of an application under subsection 9D(3) of the Act to which regulation 16D applies; and\n\n  (1) A fee is not payable in accordance with item 9AB in Part 2 of Schedule 9 for an inspection covered by the annual charge for a licence to manufacture the therapeutic goods mentioned in that item.\n  (2) An inspection is covered by the annual charge for a licence to manufacture the therapeutic goods if no more than 2 prior inspections have been carried out at the metropolitan site, identified in the licence, within the period of 3 years immediately preceding the relevant inspection.\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subregulation 16Q(1) for a therapeutic goods (priority applicant) determination in relation to the medicine; and\n\n    (b) at the same time as, or after, applying for the designation, the person applies to the Secretary under subsection 22C(1) of the Act for a provisional determination in relation to the medicine; and\n    (c) the person pays the fee prescribed in item 1AA of the table in clause 3 of Schedule 9 for applying for the determination; and\n\n  If:\n    (c) the Secretary makes a decision on the request but not within the period specified for the request in regulation 16GG;\n\n  If, during the period beginning on 1 January 2025 and ending at the end of the day before this regulation commences, a person paid a fee covered by item 1AFA of the table in clause 3 of Schedule 9 or by item 2B of the table in Part 2 of Schedule 9A, the Secretary must refund the fee to the person.\n\n  If a person asks the Department to test a sample of goods, the costs incurred by the Department in carrying out that testing are recoverable from that person as a debt due to the Commonwealth.\n\n  Reduction of evaluation fee for certain goods—supply in the interest of public health that would otherwise not be commercially viable\n  (1) The Secretary may reduce by 70% the amount of the evaluation fee specified in Schedule 9 that is payable in relation to the supply of therapeutic goods (other than goods of a kind mentioned in Part 1 of Schedule 10) if the supply of those goods:\n  (2) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10) if the applicant makes another application, or other applications, in relation to therapeutic goods at the same time and the following circumstances apply:\n    (b) the information given in support of each application has sufficient commonality, in respect of the goods, that a simultaneous evaluation of the goods may conveniently be made.\n  Waiver or reduction of application and evaluation fees for certain medicines—additional applications for goods with same active ingredient and common information\n  (3A) The Secretary may waive or reduce the application and evaluation fees specified in Schedule 9 that are payable in relation to an application if:\n    (d) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made.\n  (4) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedules 9 and 9A in relation to an application (other than an application relating to goods of a kind mentioned in Part 1 of Schedule 10):\n    (d) for a biological included in the Register under Part 3‑2A of the Act—to vary the information included in the Register;\n  Waiver or reduction of evaluation fees for supply of certain medicines in public health emergency—abridged evaluation procedure\n  (4AA) The Secretary may waive, or reduce, an evaluation fee prescribed in Schedule 9 in relation to a submission for goods of a kind mentioned in Part 1 of Schedule 10 if, in the Secretary’s opinion:\n  (4AB) The Secretary may waive an application fee or evaluation fee prescribed in Schedule 9 to these Regulations in relation to an application under section 23 of the Act if:\n    (b) the Secretary is satisfied that the medicine is suitable for repurposing under the program known as the Medicines Repurposing Program.\n  Reduction of application and evaluation fees for certain medicines—abridged preliminary assessment and evaluation procedure\n  (5) Subregulation (6) applies in relation to an application made under section 23 of the Act for the registration of a medicine if:\n    (b) apart from the directions for use or the dosage model, the medicine is the same as another medicine that is included in the Register; and\n    (i) the differences in the directions for use or the dosage model are necessary to ensure the safe use of the medicine; and\n    (d) the Secretary has information relating to the medicine that enables the preliminary assessment of the application and the evaluation of the medicine for registration to be abridged.\n  (7) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request (an opioid reform request) that satisfies all of the following:\n    (b) it is made in the period beginning on the commencement of this subregulation and ending at the end of 31 December 2021;\n    (d) it is made solely for an opioid reform purpose (see subregulation (8)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (9)).\n    (i) add a warning, or precaution, in relation to the goods that does not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (9) For the purposes of subregulation (7), an opioid reform request is made for an associated variation of product information purpose if:\n    (c) the request is made for the purpose of varying product information in relation to the prescription opioids so that the product information is in the form approved under section 7D of the Act in relation to the prescription opioids.\n    (a) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22C(1) of the Act relating to a medicine that is a designated orphan drug;\n    (b) a fee that would have been payable, but for this subregulation, as part of an application under subsection 22E(3) of the Act relating to a medicine that is a designated orphan drug;\n    (c) a fee that would have been payable, but for this subregulation, as part of the registration of a designated orphan drug;\n    (d) a fee that would have been payable, but for this subregulation, for applying for a therapeutic goods (priority applicant) determination in relation to a medicine that is a designated orphan drug.\n  (13) The Secretary must waive a fee prescribed in Schedule 9 in relation to a request that a person makes under subsection 9D(3) of the Act if:\n    (d) the request is made solely for the purpose of varying product information in relation to the medicine so that the product information is in the form approved under section 7D of the Act in relation to the medicine; and\n\n  (1) Subject to subregulation (7), the Secretary may allow the amount of a fee payable under item 4, 5, 6, 10 or 11 in Schedule 9A to be paid in instalments, if:\n    (c) the Secretary is reasonably satisfied that the applicant will experience financial hardship if that amount is paid before the commencement of the evaluation to which the fee relates; and\n    (a) state the reasons why payment of the full amount of the fee before the evaluation commences will cause financial hardship to the applicant; and\n  (3) If the Secretary reasonably requires information or material in addition to the documents or material referred to in paragraph 2(b), the Secretary may require the applicant to provide the information or material to the Secretary.\n    (b) 25% of the fee is due for payment at the end of 1 month after the day on which the amount referred to in paragraph (a) is due for payment; and\n    (ii) if the Secretary refuses the application to include the biological in the Register—when the applicant is notified under section 32DG of the Act; or\n    (a) give notice in writing to the applicant within 30 days of receiving the application whether the application has been approved; and\n    (b) if the application is approved—include with the notice information about the amounts of the instalments and when the instalments are due for payment.\n  (7) This regulation does not apply while another evaluation fee, or an assessment fee payable under section 41LA of the Act (or part of either of those kinds of fee), that is due for payment by the applicant is unpaid.\n\n  (1) The Secretary is to ensure that each authorised officer is issued with an identity card that incorporates a recent photograph of the person.\n  (2) When a person ceases to be an authorised officer, the person must, as soon as practicable after so ceasing, return the person’s identity card to the Secretary.\n\n  (1) For paragraph 57(1)(c) of the Act, the secondment of a person employed by a national therapeutic goods regulatory authority of another country to a position in the Department is declared to be an appointment the occupant or holder of which may be a delegate under section 57 of the Act.\n\n  (1) For the purposes of paragraph (ga) of the definition of protected person in subsection 61A(4) of the Act, the following kinds of persons are prescribed:\n    (b) any other person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: A person assisting a person prescribed by this subregulation is also a protected person: see paragraph (h) of the definition of protected person in subsection 61A(4) of the Act.\n\n  (2) For the purposes of paragraph (b) of the definition of protected person in subsection 62(3) of the Act, the following kinds of persons are prescribed:\n    (b) a person who conducts a test on a sample (or part of a sample) of goods under an arrangement under paragraph 25(2)(b) of these Regulations (whether or not that person is a party to the arrangement);\n    (c) a person assisting an analyst or a person mentioned in paragraph (b) of this subregulation in relation to the testing of a sample (or part of a sample) of goods under Part 5 of these Regulations;\n    (d) a person with whom an analyst makes an arrangement under paragraph 25(2)(b) of these Regulations, or a person who makes the arrangement on behalf of a body.\n\n> Note: An analyst is also a protected person: see paragraph (a) of the definition of protected person in subsection 62(3) of the Act.\n\n  (2) For the purposes of subsection 61(6) of the Act, the Secretary may release to a person, on application by the person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:\n    (e) if the goods are medicines or biologicals, medical devices that contain medicines or biologicals, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine or biological that is intended to act on a patient in a way that is ancillary to the device:\n  (4) For the purposes of subsection 61(6) of the Act, the Secretary may release therapeutic goods information of a kind that a court, tribunal, authority, or other body or person may require to be given or produced under a law of the Commonwealth, or of a State or Territory.\n\n  (1) The Secretary may delegate a power or function of the Secretary under these Regulations to an officer of the Department.\n\n> delegation means a delegation, under subsection 57(3) of the Act, of powers of the Secretary under any of the following provisions of the Act:\n\n    (b) subject to subregulation (3), is proposed by the medical superintendent or, if there is no medical superintendent, the person occupying a position comparable to that of medical superintendent, of the institution, as a person to be a delegate under subsection 57(3) of the Act.\n  (4) A delegation must describe the person or class of persons to be treated with the therapeutic goods, biologicals or devices to which the delegation relates.\n    (a) a medical practitioner, other than the delegate, has stated in writing that the person to be treated with the biological, a kind of medical device or other therapeutic goods to which the approval relates has an illness or condition that requires treatment with the biological, medical device or other therapeutic goods; and\n    (b) an ethics committee has agreed to the granting of approval under paragraph 19(1)(a), 32CK(1)(d) or 41HB(1)(d) of the Act for the use, in the circumstances in which the delegate grants the approval, of the biological, kind of medical device or other therapeutic goods to which the delegation relates.\n\n    (b) a person authorised under subsection 19(5), 32CM(1) or 41HC(1) of the Act to supply a medicine, biological or medical device;\n    (a) list each biological, kind of medical device and other item of therapeutic goods approved by the person during the period to which the report relates; and\n    (b) state the number of new approvals, and the number of repeat approvals, of medicines, biologicals and medical devices that the person gave during that period.\n  (4) A report by a person mentioned in paragraph (1)(b) must list each biological, kind of medical device and other item of therapeutic goods supplied by the person during the period to which the report relates.\n\n> eligible person, in relation to an initial decision specified in column 1 of an item of the following table, means a person specified in column 2 of the item.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:354.4pt; margin-left:56.7pt; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"width:343.6pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Eligible persons in relation to initial decisions</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Initial decision</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span></p><p class=\"TableHeading\"><span>Eligible person</span></p></td></tr></thead><tbody><tr><td style=\"width:24.9pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:151.95pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>initial decision not covered by another item of this table</span></p></td><td style=\"width:145.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>a person whose interests are affected by the initial decision</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to make a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>3</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>decision to revoke a therapeutic goods (priority applicant) determination or biologicals (priority applicant) determination</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-inside:avoid; page-break-after:avoid\"><span>the priority applicant specified in the determination</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to refuse to approve an application for approval</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who applied for the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision under regulation</span><span> </span><span>10JE or 10JF to revoke or vary an approval of a specified person to import or export mercury</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person specified in the approval</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5A</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision to refuse to waive a fee under subregulation</span><span> </span><span>45(4AB) following an application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the person who made the application referred to in subregulation</span><span> </span><span>45(4AC)</span></p></td></tr><tr><td style=\"width:24.9pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:151.95pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>decision covered by subregulation (1AB)</span></p></td><td style=\"width:145.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the sponsor concerned</span></p></td></tr></tbody></table>\n```\n\n  (1AA) Each of the following decisions of the Secretary under regulation 10JE or 10JF (about importing or exporting mercury) is an initial decision:\n    (a) a decision to refuse to agree to a notification covered by paragraph (a) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (b) a decision to refuse to agree to a notification covered by paragraph (ha) of column 3 of item 3 of the table in Schedule 5A being given before the end of a period nominated by the sponsor concerned;\n    (c) a decision to make goods the subject of a determination as referred to in paragraph (g) of column 2 of item 15 of the table in Schedule 5A.\n  (1A) The Minister may, by signed instrument, delegate a power or function of the Minister under this regulation to an officer of the Department.\n  (2) An eligible person in relation to an initial decision may request the Minister to reconsider the decision by notice in writing given to the Minister within 90 days after the decision first comes to the person’s notice.\n  (3) The Minister must reconsider the initial decision as soon as practicable after receiving a request under subregulation (2), and may:\n    (b) the Minister must not take into account any other information provided by, or on behalf of, the person after the making of the request, other than information provided in response to a request from the Minister.\n  (3B) Paragraph (3A)(a) does not otherwise limit the information the Minister may take into account in reconsidering the initial decision.\n  (3C) If, under paragraph (3)(b), the Minister revokes an initial decision and makes a decision in substitution for the initial decision, then the substituted decision:\n  (4) If a person who has made a request under subregulation (2) does not receive notice of the decision of the Minister on reconsideration within 60 days of the making of the request, the Minister is to be taken to have confirmed the original decision.\n  (5) After reconsideration of an initial decision, the Minister must give the applicant a notice in writing stating the result of the reconsideration and that the applicant may, except where subsection 269(7) of the Administrative Review Tribunal Act 2024 applies, apply for a statement setting out the reasons for the decision on reconsideration and may, subject to that Act, make an application to the Administrative Review Tribunal for review of that decision.\n  (6) If written notice of the making of an initial decision is given to a person who is an eligible person in relation to the decision, the notice is to include a statement to the effect that the person may:\n    (b) subject to the Administrative Review Tribunal Act 2024, if the person is dissatisfied with the decision upon reconsideration, make an application to the Administrative Review Tribunal for review of that decision.\n  (7) Any failure to comply with the requirements of subregulation (5) or (6) in relation to a decision does not affect the validity of the decision.\n\n> finally determined has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transitional device has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> transition day, for a transitional device, has the same meaning as in Division 11.1 of Part 11 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n  (1) The amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to a transitional device on and after the transition day for the device.\n    (b) an effective application for including a transitional device in the Register under Chapter 4 of the Act was made before 1 July 2014 and the application was finally determined before that date;\n  the amendments made by Schedule 1 to the 2010 Amendment Regulations apply in relation to the device on and after 1 July 2014.\n\n    (b) paragraph (g) of item 8 of Schedule 5, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act on 9 November 2012; and\n    (c) paragraph (b) of item 14 of Schedule 7, as in force on 9 November 2012, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act on 9 November 2012.\n\n### Division 3—Transitional provisions relating to the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015\n\n  The amendments made by the Therapeutic Goods Amendment (Registered Over the Counter Medicines) Regulation 2015 apply in relation to applications and requests made on or after 1 January 2016.\n\n### Division 4—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016\n\n  (1) The amendments made by Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to an event or change of name that occurs on or after the day that Part commences.\n  (2) The amendments made by items 24, 25 and 26 of Part 3 of Schedule 4 to the Therapeutic Goods Legislation Amendment (Charges Exemptions and Other Measures) Regulation 2016 apply in relation to requests made on or after the day that Part commences.\n\n### Division 5—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 1) Regulations 2017\n\n  (1) This regulation applies if, before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017:\n    (a) an application had been made under subsection 26BD(1) of the Act (as in force immediately before that commencement) for a variation of a determination under subsection 26BB(1) of the Act; and\n    (c) the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before that commencement) in relation to the application had not been paid.\n  (2) Despite the amendments made by Schedule 3 to the 2017 Amendment Regulations, the evaluation fee prescribed by item 7C or 7D, as the case may be, of the table in clause 3 of Schedule 9 (as in force immediately before the commencement of Schedule 5 to the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017) continues to apply in relation to the application.\n\n  (1) This regulation applies if a designation by the Secretary under regulation 16J (as in force immediately before the commencement day) of a medicine, vaccine or in vivo diagnostic agent as an orphan drug was in force immediately before the commencement day.\n\n    (a) a person had applied to the Secretary under regulation 16I (as in force before the commencement day) to designate a medicine, vaccine or in vivo diagnostic agent as an orphan drug; and\n  (2) Despite the amendments made by Schedule 7 to the 2017 Amendment Regulations, Part 3B (as in force immediately before the commencement day) and regulation 48 (as in force immediately before the commencement day) continue to apply in relation to the application.\n  (3) If the medicine, vaccine or in vivo diagnostic agent is designated as an orphan drug under regulation 16J (as in force immediately before the commencement day):\n    (b) while the designation is in force, regulation 43AD applies in relation to the medicine, vaccine or in vivo diagnostic agent as if it had been designated as an orphan drug under regulation 16J.\n\n  (1) This regulation applies in relation to a designation of a medicine, vaccine or in vivo diagnostic agent as an orphan drug if the designation is in force under regulation 54 or 55.\n  (2) The medicine, vaccine or in vivo diagnostic agent is taken to be a designated orphan drug for the purposes of the following provisions:\n\n### Division 6—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2017 Measures No. 2) Regulations 2017\n\n  The amendments of regulation 12A of these Regulations made by Part 3 of Schedule 4 to the Amendment Regulations apply in relation to a medicine or a biological given to a person on or after the commencement day.\n\n  (2) The approval has effect, on and after the commencement day, as if it had been made for the purposes of subparagraph 12A(2)(a)(iii) of these Regulations as amended by the Amendment Regulations.\n\n### Division 7—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018\n\n  (1) The amendment of regulation 9B made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to the supply of goods on or after the commencement of this regulation.\n  (2) The amendments of regulation 16J made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to applications made under subregulation 16H(1) on or after the commencement of this regulation.\n  (3) The amendment of regulation 16R made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 applies in relation to applications made under subregulation 16Q(1) on or after the commencement of this regulation.\n  (4) Regulation 43AE, as inserted by Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, applies in relation to applications made under regulation 16H on or after the commencement of this regulation.\n\n  (1) The amendments made by items 7, 14, 15, 16 and 33 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 apply in relation to requests or applications made on or after the commencement of this regulation.\n  (2) The amendments made by items 26 to 32 of Schedule 2 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018 do not apply in relation to requests or applications made before the commencement of this regulation.\n\n  Division 5 of Part 2 and regulation 48, as in force immediately before the commencement of Part 1 of Schedule 4 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 1) Regulations 2018, continue to apply on and after that commencement in relation to an order given under subregulation 9(1) before that commencement.\n\n### Division 8—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018\n\n  The amendments of these Regulations made by the Therapeutic Goods Legislation Amendment (Exempt Devices and Goods) Regulations 2018 apply to a therapeutic good imported into Australia:\n    (b) during the 12 months ending immediately before that commencement, if the goods were held under the direct control of the sponsor immediately before that commencement.\n\n### Division 9—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 2) Regulations 2018\n\n> finally determined has the same meaning as in Division 11.1 of the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n    (c) to which column 2 of item 13 of Schedule 5A to these Regulations, as inserted by the Amendment Regulations, does not apply.\n\n  (1) For the purposes of subsections 18(1) and 32CA(2) of the Act, transitional goods are exempt from the operation of the following provisions of the Act:\n  (2) The exemptions mentioned in subregulation (1) are subject to compliance with the condition that, if the sponsor of the goods knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n    (a) a sponsor of transitional goods applies, on or before 30 June 2019, for registration, listing, or inclusion of the goods in the Register; and\n  subregulation (1) ceases to have effect in relation to the goods when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2019.\n  (5) If a sponsor of transitional goods applies, on or before 30 June 2019, for an approval under section 32CK in relation to the goods, subregulation (1) ceases to have effect in relation to the goods when the application is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n  (6) While subregulation (1) has effect in relation to transitional goods, paragraph 7(e) applies to the goods in the same way as that paragraph applies to goods mentioned in column 2 of an item in Schedule 5A.\n\n  (1) For the purposes of subsection 34(1) of the Act, transitional goods are exempt from the operation of Part 3‑3 of the Act.\n  (3) If, on or before 30 June 2019, each person who carries out a step in the manufacture of transitional goods applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (1) ceases to have effect in relation to the transitional goods produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2019.\n\n### Division 10—Application provisions relating to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018\n\n  The amendments of Schedules 3, 4 and 5 made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2018 Measures No. 3) Regulations 2018 apply to disinfectants after the commencement of that Division, whether or not the disinfectants were registered goods or listed goods immediately before that commencement.\n\n> Note: If disinfectants were registered goods immediately before that commencement, subregulation 10B(2) lets the persons in whose names the goods were entered in the Register immediately before that commencement apply to the Secretary:\n\n### Division 11—Application and transitional provisions relating to the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019\n\n  (1) The amendment of regulation 43A made by the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019 applies in relation to applications made on or after 6 September 2019.\n  (2) If, on or after 6 September 2019 and before the commencement of the Therapeutic Goods Amendment (Fees for Relisted Medicine) Regulations 2019, a person:\n    (a) made an application for the listing of medicine in circumstances where paragraphs 43A(4)(a) to (c) were satisfied; and\n\n### Division 12—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019\n\n  (1) For the purposes of subsection 32CA(2) of the Act, faecal microbiota transplant products are exempt from the operation of Division 4 of Part 3‑2A of the Act.\n  (2) The exemption mentioned in subregulation (1) is subject to compliance with the condition that, if the sponsor of the faecal microbiota transplant products knows that particular information relating to an event or occurrence indicates that use of the products as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB.\n  (4) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for inclusion of the products in the Register, subregulation (1) ceases to have effect in relation to the products when the application is finally determined, lapses or is withdrawn, if that happens on or after 1 July 2021.\n  (5) If a sponsor of faecal microbiota transplant products applies, on or before 30 June 2021, for an approval under section 32CK of the Act in relation to the products, subregulation (1) ceases to have effect in relation to the products when the application is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (2) For the purposes of subsection 34(1) of the Act, transitional biologicals are exempt from the operation of Part 3‑3 of the Act.\n  (4) If, on or before 30 June 2021, each person who carries out a step in the manufacture of transitional biologicals applies for a licence authorising the person to carry out the step on premises referred to in the application, subregulation (2) ceases to have effect in relation to the transitional biologicals produced by those persons carrying out the steps on those premises when the last of those applications is finally determined or is withdrawn, if that happens on or after 1 July 2021.\n\n  (1) Subject to this regulation, the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to medicines supplied on and after 1 January 2021.\n  (2) Subject to subregulation (3), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional medicine) that immediately before 1 January 2021 was a registered good.\n  (3) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional medicines on and after 1 January 2026.\n\n  (4) Subject to subregulation (5), the amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations do not apply in relation to supplies of a medicine of a kind (a transitional application medicine) while either of the following applies to the transitional application medicine:\n    (a) it is the subject of an application for registration that was made before 1 January 2021 and that immediately before that date was not finally determined;\n  (5) The amendments of regulations 9A and 9B and Schedules 12 and 13 made by Schedule 6 to the amending regulations apply in relation to supplies of transitional application medicines on and after 1 January 2026.\n\n  (1) The insertion of subregulations 45(7) to (9) by Schedule 8 to the amending regulations applies in relation to requests made on or after the commencement of those subregulations.\n    (iii) was made solely for an opioid reform purpose (see subregulation (3)) or solely for an opioid reform purpose and an associated variation of product information purpose (see subregulation (4)); and\n  (3) For the purposes of subregulation (2), an opioid reform request was made for an opioid reform purpose if it was made:\n    (i) add a warning, or precaution, in relation to the goods that did not include any comparison of the goods with any other therapeutic goods by reference to quality, safety or efficacy;\n  (4) For the purposes of subregulation (2), an opioid reform request was made for an associated variation of product information purpose if:\n    (c) the request was made for the purpose of varying product information in relation to the prescription opioids so that the product information would be in the form approved under section 7D of the Act in relation to the prescription opioids.\n\n  (1) These Regulations have effect as if a written assurance given before 1 January 2020 under paragraph 12AB(2)(a) that clinical trials would be conducted in accordance with the Practice Guidelines were, on and after 1 January 2020, a written assurance that clinical trials would be conducted in accordance with the Practice Guideline.\n  (2) The amendment of subregulation 12AC(1) made by Part 2 of Schedule 9 to the amending regulations applies in relation to things done on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n  (3) The amendment of paragraph 12AD(a) made by Part 2 of Schedule 9 to the amending regulations applies in relation to uses on or after 1 January 2020 in relation to a clinical trial that began before, on or after 1 January 2020.\n\n### Division 13—Application and saving provisions relating to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020\n\n  Subregulation 12B(1B), as inserted by Schedule 4 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  (1) The amendments of regulation 16GI and of items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9 made by Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020 apply in relation to an application made under subsection 26BD(1) of the Act on or after the commencement of those amendments.\n  (2) Regulation 16GI and items 28, 30, 32 and 34 of the table in clause 5 of Schedule 9, as in force immediately before the commencement of Schedule 6 to the Therapeutic Goods Legislation Amendment (2020 Measures No. 1) Regulations 2020, continue to apply on and after that commencement in relation to an application made under subsection 26BE(1) of the Act before that commencement.\n\n### Division 15—Application provisions relating to the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021\n\n  The amendments of these Regulations made by the Minamata Convention on Mercury (Consequential Amendments) Regulations 2021 apply in relation to the importation into, export from, or manufacture in, Australia of therapeutic goods on or after the commencement of that instrument.\n\n### Division 16—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021\n\n  Item 1B of the table in Schedule 5A, as inserted by Part 9 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021, applies in relation to therapeutic goods imported into Australia on or after the commencement of that Part.\n\n  The amendments of regulation 9A (except the amendment of paragraph 9A(1A)(b)) made by Part 10 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to supplies of therapeutic goods on or after the commencement of that Part (whether the goods were included in the Register before, on or after that commencement).\n\n  The amendments of regulation 12B made by Part 11 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021 apply in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Part.\n\n### Division 17—Application provisions relating to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021\n\n  (1) The amendment of paragraph 7(g) made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to an advertisement that is made on or after the commencement of that amendment.\n  (2) The amendment of item 1B of the table in Schedule 5A made by Division 1 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 applies in relation to therapeutic goods imported into Australia on or after the commencement of that amendment.\n\n  (1) The amendments of regulation 6B and of Part 1 of Schedule 2 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to an advertisement that is made on or after the commencement of those amendments.\n  (2) The amendments of regulation 8 made by Division 2 of Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2021 Measures No. 4) Regulations 2021 apply in relation to the dissemination of generic information on or after the commencement of those amendments.\n\n### Division 18—Application provisions relating to Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendment of Schedule 5 to these Regulations made by Schedule 1 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 does not apply in relation to a medicinal cannabis product that is extemporaneously compounded before 28 April 2022.\n\n### Division 19—Application provisions relating to Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022\n\n  The amendments of regulation 48 of these Regulations made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 1) Regulations 2022 apply in relation to initial decisions made on or after the commencement of this regulation.\n\n### Division 20—Application provisions relating to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022\n\n  The amendment of item 1 of the table in Schedule 5 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to therapeutic goods that are imported on or after the commencement of this regulation.\n\n  (1) The amendment of item 2A of the table in clause 3 of Schedule 9 made by Schedule 2 to the Therapeutic Goods Legislation Amendment (2022 Measures No. 3) Regulations 2022 applies in relation to a request that is made on or after the commencement of this regulation.\n    (a) on or after 1 January 2022 and before the commencement of this regulation, a person made a request of a kind covered by paragraph (c) of item 2A of the table in clause 3 of Schedule 9 (as that item was in force before that commencement); and\n    (b) on or after 1 January 2022 and before the commencement of this regulation, the person paid the fee applicable in relation to the request under paragraph (c) of that item (as that item was in force before that commencement); and\n    (c) had the request been made on the day on which this regulation commences, the request would have been covered by paragraph (d) of that item as in force on that commencement;\n  the Secretary must, on behalf of the Commonwealth, refund to the person the difference between the fee paid and the fee that would have been applicable in relation to the request under paragraph (d) of that item if the request had been made on the day on which this regulation commences.\n\n### Division 21—Application provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023\n\n  The amendments of item 3 of the table in Schedule 5A made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 1) Regulations 2023 apply in relation to the use of therapeutic goods on or after the commencement of those amendments, whether the clinical trial began before, on or after that commencement.\n\n### Division 22—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023\n\n  The amendments of subregulation 12AC(1) of these Regulations made by Part 2 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 apply in relation to things done on or after the commencement of those amendments in relation to a clinical trial that began before, on or after that commencement.\n\n  Despite the amendments of Schedules 5 and 7 to these Regulations made by Part 5 of Schedule 1 to the Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023:\n    (a) paragraph (g) of item 8 of Schedule 5 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act immediately before that commencement; and\n    (b) item 14 of Schedule 7 to these Regulations, as in force immediately before the commencement of those amendments, continues to apply until the end of 31 December 2026 in relation to therapeutic goods exempt from the operation of Part 3‑3 of the Act immediately before that commencement.\n\n### Division 23—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping) Regulations 2023\n\n  The amendment of subregulation 12B(1B) of these Regulations made by Schedule 1 to the amending regulations applies in relation to an authority given under subsection 19(5) of the Act on or after 1 January 2024.\n\n  The amendments of Schedules 3 and 4 to these Regulations made by Schedule 1 to the amending regulations apply to therapeutic vaping substances, therapeutic vaping substance accessories and therapeutic vaping kits from 1 January 2024.\n\n  (1) Paragraph (b) of item 1 of the table in Schedule 5 to these Regulations, and item 1A of the table in Schedule 5 to these Regulations, as inserted by Schedule 1 to the amending regulations, apply in relation to:\n  (2) The repeal of items 5 and 5A of the table in Schedule 5 to these Regulations, and of the definition of nicotine vaping product in regulation 2 of these Regulations, by Schedule 1 to the amending regulations applies in relation to:\n  (3) The amendment of item 9 of the table in Schedule 5 to these Regulations made by Schedule 1 to the amending regulations applies in relation to starting materials imported on or after 1 March 2024.\n  (4) The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after 1 March 2024.\n  (5) Item 15 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported or manufactured before, on or after 1 March 2024.\n  (6) Item 16 of the table in Schedule 5A to these Regulations, as inserted by Schedule 1 to the amending regulations, applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n    (b) the person was, as at 2 May 2023, carrying out an equivalent step in the manufacture of other goods that were the same kind of goods as the therapeutic goods referred to in paragraph (a) except that the other goods were not therapeutic goods; and\n    (c) before carrying out the step referred to in paragraph (a), the person has notified the Secretary, in a form approved under subregulation (2), in relation to the step referred to in paragraph (b).\n  (3) For the purposes of subsection 34(2) of the Act, the transitional vaping manufacturer is exempt from the operation of Part 3‑3 of the Act in relation to the step in manufacture referred to in paragraph (1)(a) of this regulation.\n\n  The amendment of item 1 of the table in Schedule 5A to these Regulations made by Schedule 1 to the Therapeutic Goods Amendment (2024 Measures No. 1) Regulations 2024 applies in relation to therapeutic goods imported on or after 1 March 2024.\n\n### Division 25—Transitional provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 2) Regulations 2024\n\n  Subregulation 45(4AB) of these Regulations, as inserted by Part 1 of Schedule 1 to the amending regulations, applies in relation to an application made on or after the commencement of that Schedule.\n\n  An identity card that had been issued to an authorised officer under regulation 33 of these Regulations before the commencement of Schedule 1 to the amending regulations, and that was in the possession of the authorised officer immediately before that commencement, is taken after that commencement to have been issued to the authorised officer under regulation 46AA of these Regulations.\n\n  (1) Subject to subregulations (2) and (3) of this regulation, the amendments of these Regulations made by Part 1 of Schedule 2 to the amending regulations apply to sunscreen preparations from 1 July 2024.\n  (2) If a sunscreen preparation was listed goods immediately before 1 July 2024, paragraph (a) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2029 as if the amendments had not been made.\n  (3) If a sunscreen preparation that is supplied as an aerosol or in a spray pump pack was listed goods immediately before 1 July 2024, paragraph (b) of the column headed “Therapeutic goods” in item 7 of the table in Schedule 4 to these Regulations applies in relation to the sunscreen preparation during the period beginning on 1 July 2024 and ending on 30 June 2025 as if the amendments had not been made.\n\n### Division 26—Application and transitional provisions relating to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024\n\n  Regulation 12BA, as inserted by Schedule 1 to the amending regulations, applies in relation to an authority given under subsection 19(5) of the Act on or after the commencement of that Schedule.\n\n  The amendment made by item 17 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured on or after 1 October 2024.\n\n  (1) The amendment made by item 27 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported or manufactured before, on or after the commencement of that Schedule.\n  (2) The amendments made by items 26 and 28 to 30 of Schedule 1 to the amending regulations apply in relation to therapeutic goods imported or manufactured on or after the commencement of that Schedule.\n  (3) The amendment made by item 31 of Schedule 1 to the amending regulations applies in relation to therapeutic goods imported on or after the commencement of that Schedule.\n\n  (1) For the purposes of this regulation, therapeutic goods that are exported from Australia are transitional vaping goods if:\n    (b) the goods were imported into, or manufactured in, Australia before the commencement of Schedule 1 to the amending regulations; and\n    (c) as at that commencement, the importation or manufacture, or any supply, of the goods was done in accordance with any applicable laws of the Commonwealth or of a State or Territory.\n  (2) For the purposes of subsection 18(1) of the Act, transitional vaping goods are exempt from the operation of Part 3‑2 of the Act (except sections 30EA, 31A and 31C to 31F).\n  (3) Subregulation (2) ceases to have effect at the end of the period of 6 months starting on the day Parts 1 to 3 of Schedule 1 to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 commence.\n\n### Division 27—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024\n\n  (1) Subject to this regulation, the amendments of paragraph 48(1AB)(c), and item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, apply in relation to therapeutic goods that are:\n    (b) for therapeutic goods owned by, or in the possession or control of, the sponsor immediately before the commencement day—supplied on or after the commencement day.\n  (2) The substitution of paragraph (c) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to information or evidence held by the sponsor on or after the commencement day.\n  (3) Paragraph (e) of column 3 in item 15 of the table in Schedule 5A, as substituted by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that paragraph on or after the commencement day.\n  (4) The amendment to subparagraph (j)(ii) of column 3 in item 15 of the table in Schedule 5A, made by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n  (5) Subparagraph (j)(iii) of column 3 in item 15 of the table in Schedule 5A, as added by Part 1 of Schedule 1 to the amending regulations, applies in relation to a request made by the Secretary under that subparagraph on or after the commencement day.\n\n    (a) given before the commencement day, under paragraph (a) (the old provision) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it had been given under paragraph (e) (the new provision) of column 2 in that item (and a statement given in the notice under a subparagraph of the old provision has effect on and after the commencement day as if it had been given under the corresponding subparagraph of the new provision).\n    (a) as referred to in paragraph (e) of column 3 in item 15 of the table in Schedule 5A as in force immediately before that day; and\n  has effect on and after the commencement day as if it were a determination referred to in paragraph (g) of column 2 in that item.\n\n### Division 28—Application, transitional and saving provisions relating to the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## 112 Definitions\n\n> amending regulations means the Therapeutic Goods Legislation Amendment (Testing of Goods and Other Measures) Regulations 2025.\n\n## 113 Sampling and testing\n\n  (1) Despite the repeal of regulations 23 and 25 to 30 by the amending regulations, those provisions (other than subregulation 25(1)), as in force immediately before the commencement day, continue to apply, subject to subregulation (4) of this regulation, in relation to a sample (or part of a sample) of goods that was:\n    (a) a certificate, issued under regulation 29 or 30, that was in effect immediately before the commencement day continues to have effect; and\n    (b) regulations 29 and 30, as in force immediately before the commencement day, continue to apply (as relevant), subject to subregulation (4) of this regulation, in relation to the certificate;\n  (3) Despite the repeal of the definitions of analysis and sample in regulation 2 by the amending regulations, those definitions, as in force immediately before the commencement day, continue to apply for the purposes of subregulations (1) and (2) of this regulation as if the repeal had not occurred.\n  (4) In subregulations 25(3) to (5) and regulations 23 and 26 to 30 (the continuing provisions), as they continue to apply because of subregulations (1) and (2) of this regulation:\n    (a) a reference to an analyst or an official analyst is taken to be a reference to an analyst nominated under regulation 24 as in force on and after the commencement day; and\n    (b) a reference to an authorised officer is taken to be a reference to a person authorised on or after the commencement day under regulation 2A for the purposes of any provision in these Regulations, as if the person were also authorised to exercise powers under the continuing provisions.\n  (5) Regulations 25 and 26, as in force on and after the commencement day, apply in relation to a sample (or part of a sample) of goods that is or was obtained, accessed or given (however described) before, on or after the commencement day other than as described in paragraphs (1)(a) and (b) of this regulation.\n\n## 114 Protected persons\n\n  The substitution of regulation 46B made by the amending regulations applies in relation to anything done, or omitted to be done, by a person on or after the commencement day.\n\n## Part 1 Prohibited representations\n\n## Part 1—Prohibited representations\n\n| Column 1Item No. | Column 2Representation                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            | Column 3Therapeutic goods      |\n| ---------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------ |\n| 3                | a representation with respect to the use of goods in which it is stated or implied that those goods:(a) are, or contain, a vitamin—unless those goods are composed of, or contain, a substance specified in column 2 of an item in Part 3 of this Schedule or a salt or derivative of a substance and that substance is described either by the name referred to in Column 2 of that item, or by the name of its salt or derivative, or by the name specified in Column 3 of that item and not otherwise; or(b) are, or contain, a substance described as a vitamin otherwise than by a description specified in Column 2 or 3 of Part 3 of this Schedule                                                                                                         | all therapeutic goods          |\n| 4                | a representation that states or implies that:(a) analgesic consumption is safe; or(b) analgesics will relax, relieve tension, sedate or stimulate                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 | analgesics                     |\n| 5                | a representation containing a reference to bacteriostatic activity, except where it is made in conjunction with a reference to bactericidal activity                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              | disinfectants                  |\n| 6                | a representation:(a) containing reference to the Rideal‑Walker test or the Phenol Coefficient; or(b) on any label, containing a reference to the results of laboratory tests on micro‑organisms, other than a representation provided by leaflet or on a label enclosed with the goods in their package; or(c) containing a reference to the achievement of sterility except where the representation is approved in writing by the Secretary; or(d) contradicting or conflicting with the common name; or(e) that is not more specific than the common name as a description or measure of activity against micro organisms; or(f) containing a reference to an effect against viruses, except a representation that is approved in writing by the Secretary; or | disinfectants and antiseptics  |\n|                  | (g) containing a reference to an effect against Mycobacterium tuberculosis and related acid fast bacteria, except a representation that is approved in writing by the Secretary; or(h) containing a reference to the disinfection of inaccessible parts of drains                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 |                                |\n| 7                | a representation that antiseptics promote healing                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 | antiseptics                    |\n| 8                | a representation that states or implies that vitamin or mineral supplements:(a) are a substitute for good nutrition or a balanced diet; or(b) are in any way superior to or more beneficial than dietary nutrients                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                | vitamin or mineral supplements |\n| 9                | a representation that:(a) purports to show the recommended daily or dietary intake or allowance of a vitamin or a mineral unless the amount shown is that recommended by the National Health and Medical Research Council; or(b) expresses the quantity of a vitamin or a mineral contained in a preparation as a percentage or proportion of the recommended daily or dietary intake or allowance                                                                                                                                                                                                                                                                                                                                                                | vitamins and minerals          |\n| 10               | The following:(a) a representation regarding abortifacient action;(b) a representation regarding the treatment, cure, prevention, diagnosis (including screening) or monitoring of, or the susceptibility or pre‑disposition to, one or more of the following:(i) neoplastic disease;(ii) sexually transmitted diseases;(iii) human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS);(iv) hepatitis C virus (HCV);(v) mental illness                                                                                                                                                                                                                                                                                                    | all therapeutic goods          |\n\n## Part 2 Required representations\n\n## Part 2—Required representations\n\n| Column 1Item | Column 2Representation                                                                                                                                                                                                                   | Column 3Therapeutic goods                                     |\n| ------------ | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------- |\n| 1            | if the advertisement is in the form of a label on the retail container—a statement that:(a) vitamins can only be of assistance if the dietary vitamin intake is inadequate; or(b) vitamin supplements should not replace a balanced diet | vitamin preparations for oral ingestion supplied in Australia |\n\n## Part 3 Vitamins referred to in Item 3 of Part 1 of this Schedule\n\n## Part 3—Vitamins referred to in Item 3 of Part 1 of this Schedule\n\n| Column 1Item | Column 2Substance | Column 3Name |\n| ------------ | ----------------- | ------------ |\n| 1            | Vitamin A         | —            |\n| 2            | Thiamine          | Vitamin B1   |\n| 3            | riboflavin        | Vitamin B2   |\n| 4            | Nicotinic Acid    |              |\n| 5            | Pantothenic Acid  | Vitamin B5   |\n| 6            | Pyridoxine        | Vitamin B6   |\n| 7            | Cyanocobalamin    | Vitamin B12  |\n| 8            | Ascorbic Acid     | Vitamin C    |\n| 9            | Ergocalciferol    | Vitamin D2   |\n| 10           | colecalciferol    | Vitamin D3   |\n| 11           | alpha‑Tocopherol  | Vitamin E    |\n| 12           | Biotin            | Vitamin H    |\n| 13           | Phytomenadione    | Vitamin K1   |\n| 14           | Menadione         | Vitamin K3   |\n| 15           | Folic Acid        |              |\n\n","sortOrder":0},{"sectionNumber":"Sch 3","sectionType":"schedule","heading":"Therapeutic goods required to be included in the part of the Register for goods known as registered goods or as provisionally registered goods","content":"Schedule 3—Therapeutic goods required to be included in the part of the Register for goods known as registered goods or as provisionally registered goods\n\n(regulation 10)\n\n## Part 1 Medicines\n\n## Part 1—Medicines\n\n| Item No. | Therapeutic goods                                                                                                                                                                         |\n| -------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |\n| 1        | medicines that:(a) are not mentioned in item 1 of Schedule 4; and(b) are not designated orphan drugs                                                                                      |\n| 2        | medicines that:(a) are not mentioned in item 3, 4A, 5 or 7 of Schedule 4; and(b) are not designated orphan drugs; and(c) are supplied as pharmaceutical benefits                          |\n| 2A       | medicines that:(a) are not mentioned in item 1, 2, 3, 4, 6, 8, 8A, 9 or 11 in Schedule 5; and(b) are not designated orphan drugs; and(c) are supplied as pharmaceutical benefits          |\n| 2B       | medicines that:(a) are not mentioned in item 1, 1A, 3, 4, 5, 7, 8, 9, 10, 11 or 12 in Schedule 5A; and(b) are not designated orphan drugs; and(c) are supplied as pharmaceutical benefits |\n\n## Part 2 Therapeutic goods that are not medicines\n\n## Part 2—Therapeutic goods that are not medicines\n\n| Item No. | Therapeutic goods                                                                                                                     |\n| -------- | ------------------------------------------------------------------------------------------------------------------------------------- |\n| 1        | Therapeutic vaping substances, or therapeutic vaping substance accessories, to which item 1 in Part 1 of this Schedule does not apply |\n\n## Part 3 Therapeutic goods attracting no fee under Division 1 or 2 of Part 3‑2 of the Act\n\n## Part 3—Therapeutic goods attracting no fee under Division 1 or 2 of Part 3‑2 of the Act\n\n| Item No. | Therapeutic goods       |\n| -------- | ----------------------- |\n| 1        | Designated orphan drugs |\n\n","sortOrder":1},{"sectionNumber":"Sch 4","sectionType":"schedule","heading":"Therapeutic goods required to be included in the part of the Register for listed goods","content":"Schedule 4—Therapeutic goods required to be included in the part of the Register for listed goods\n\n(regulation 10)\n\n| Item No. | Therapeutic goods                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   |\n| -------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |\n| 1        | therapeutic goods manufactured in Australia for export only other than goods exempt under regulation 12                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             |\n| 3        | medicines where:(a) the medicine only contains ingredients that are specified in a determination under paragraph 26BB(1)(a) of the Act; and(b) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; and(c) the ingredients in the medicine are not of a kind required to be sterile; and(ca) the medicine does not contain a substance included in a Schedule to the Poisons Standard; and(d) the medicine only has indications that are covered by a determination under paragraph 26BF(1)(a) of the Act; and(e) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to the indications—none of the requirements have been contravened                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               |\n| 4A       | homoeopathic preparations where:(a) the preparation consists of, or contains a dilution of, mother tincture that is a 1,000 fold dilution, or a lesser dilution, of that mother tincture; and(b) the preparation only contains ingredients that are specified in a determination under paragraph 26BB(1)(a) of the Act; and(c) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the preparation—none of the requirements have been contravened; and(d) the preparation is not required to be sterile; and(e) the preparation does not contain a substance (other than one that is more than a 1,000‑fold dilution of mother tincture) included in a Schedule to the Poisons Standard; and(f) the preparation only has indications that are covered by a determination under paragraph 26BF(1)(a) of the Act; and(g) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to the indications—none of the requirements have been contravened                                                                                                                                                                                                                                                                      |\n| 5        | homoeopathic preparations where:(a) each dilution is more dilute than a 1,000 fold dilution of mother tincture; and(b) the preparation only contains ingredients that are specified in a determination under paragraph 26BB(1)(a) of the Act; and(c) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the preparation—none of the requirements have been contravened; and(d) the preparation is not required to be sterile; and(e) the preparation only has indications that are covered by a determination under paragraph 26BF(1)((a) of the Act; and(f) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to the indications—none of the requirements have been contravened                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               |\n| 7        | sunscreen preparations for dermal application, if:(a) the claimed sun protection factor has been established by testing according to the method described in Australian/New Zealand Standard AS/NZS 2604:2021, Sunscreen products ‑ Evaluation and classification, published jointly by, or on behalf of, Standards Australia and Standards New Zealand, as in force from time to time; and(b) the performance statements and markings on the label comply with that Standard; and(c) the sunscreen preparation only contains ingredients that are specified in a determination under paragraph 26BB(1)(a) of the Act; and(d) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the sunscreen preparation—none of the requirements have been contravened; and(e) the sunscreen preparation only has indications that are covered by a determination under paragraph 26BF(1)(a) of the Act; and(f) if a determination under paragraph 26BF(1)(b) of the Act specifies requirements in relation to the indications—none of the requirements have been contravened                                                                                                                                                                                         |\n| 8        | medicines to be listed under section 26AE of the Act, if:(a) the medicine only contains ingredients that are specified in a determination under paragraph 26BB(1)(a) of the Act; and(b) if a determination under paragraph 26BB(1)(b) of the Act specifies requirements in relation to ingredients being contained in the medicine—none of the requirements have been contravened; and(c) the ingredients in the medicine are not of a kind required to be sterile; and(ca) the medicine does not contain a substance included in a Schedule to the Poisons Standard; and(d) the indications proposed by the sponsor of the medicine are either:(i) uses of the medicine in preventing, curing or alleviating a disease, ailment, defect or injury in persons, other than a form of the disease, ailment, defect or injury that, under the Therapeutic Goods Advertising Code, is a serious form; or(ii) uses of the medicine in connection with alleviating a disease, ailment, defect or injury in persons, being a form of the disease, ailment, defect or injury that, under the Therapeutic Goods Advertising Code, is a serious form; and(e) the indications proposed by the sponsor of the medicine do not refer to an indication that is or contains a prohibited representation (within the meaning of Part 5‑1 of the Act |\n| 12       | kits (to be known as medicine kits) consisting as follows:(a) solely of medicines—if Part 3‑2 of the Act applies to any of the individual therapeutic goods contained in the kit;(b) of medicines and biologicals—if:(i) Part 3‑2 of the Act applies to any of the individual therapeutic goods (other than biologicals) contained in the kit; and(ii) Part 3‑2A of the Act applies to any of the biologicals contained in the kit                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  |\n| 16       | hospital grade disinfectants, or household grade disinfectants, that are claimed to be sterilants, fungicides, sporicides, tuberculocides or virucides                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              |\n| 17       | a therapeutic vaping kit, if each of the goods in the kit is a registered good                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      |\n\n","sortOrder":2},{"sectionNumber":"Sch 5","sectionType":"schedule","heading":"Therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act","content":"Schedule 5—Therapeutic goods exempt from the operation of Parts 3‑2 and 3‑2A of the Act\n\n(subregulation 12(1))\n\n| Column 1Item No. | Column 2Therapeutic goods                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      |\n| ---------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |\n| 1                | therapeutic goods that are imported for use in the treatment of the importer or the importer’s immediate family where:(a) the goods do not contain a substance the importation of which is prohibited under the Customs Act 1901; and(b) the goods are not any of the following:(i) disposable therapeutic vapes;(ii) therapeutic vaping substances;(iii) therapeutic vaping substance accessories;(iv) a therapeutic vaping kit;(v) goods in a therapeutic vaping pack; and(ba) for a biological—the biological is the subject of an approval under section 32CK of the Act; and(c) in the case of other medicines:(i) the quantity imported in one importation is not more than 3 months’ supply at the maximum dose recommended by the manufacturer; and(ii) the total quantity of the medicine imported for use in the treatment of the importer or the importer’s immediate family in the period of 12 months ending on the day on which the latest importation occurs does not exceed 15 months’ supply of the medicine at the maximum dose recommended by the manufacturer;or the medicines have been approved, or are included in a class of medicines that has been approved, under regulation 5 of the Customs (Prohibited Imports) Regulations 1956 for importation into Australia; and(d) if the goods are subject to Schedule 4 or Schedule 8 to the Poisons Standard—the goods are the subject of a written authority issued by a medical practitioner, except where the goods are carried by the importer as a passenger on a ship or aeroplane |\n| 1A               | therapeutic goods that are disposable therapeutic vapes, therapeutic vaping substances or therapeutic vaping substance accessories, imported into Australia by a person (the first person) on board a ship or aircraft, if:(a) the therapeutic goods are for use in the treatment of the first person or one or more other persons on board the ship or aircraft under the care of the first person; and(b) the importation of the therapeutic goods meets the requirements of paragraph 5(2)(b) or subregulation 5A(2) of the Customs (Prohibited Imports) Regulations 1956                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   |\n| 2                | therapeutic goods that are exported and that:(a) are not for commercial supply; and(b) do not contain a substance the exportation of which is prohibited under the Customs Act 1901; and(c) are not intended for use in clinical trials on humans                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              |\n| 3                | samples of therapeutic goods imported, exported, manufactured, or supplied for:(a) submission to a regulatory authority; or(b) subjection to developmental or quality control procedures; or(c) examination, demonstration or display; or(d) subjection to laboratory testing procedures;but not for supply for therapeutic use in humans                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      |\n| 4                | goods imported solely for the purpose of export that remain subject to customs control under the Customs Act 1901 and that are not subject to manufacture in Australia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         |\n| 6                | medicines that are dispensed, or extemporaneously compounded, for a particular person for therapeutic application to that person, other than the following:(a) medicines that are used for gene therapy;(b) medicines that are medicinal cannabis products;(c) medicines that contain glucagon‑like peptide‑1 (GLP‑1) receptor agonist analogues                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               |\n| 6A               | medicines (other than medicines that are used for gene therapy or that are medicinal cannabis products) that are:(a) compounded in a hospital by:(i) in the case of a private hospital—a hospital pharmacist who is engaged in the manufacture of therapeutic goods (other than biologicals) on the premises of the private hospital; or(ii) in the case of a public hospital—a pharmacist who is employed by the public hospital and is engaged in the manufacture of therapeutic goods (other than biologicals); and(b) compounded in anticipation of being needed for therapeutic application to patients of the hospital; and(c) considered by the hospital’s drug and therapeutic committee (however called) to be appropriate for compounding in anticipation of being needed to treat a patient at the hospital                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         |\n| 7                | manufacturing, laboratory and dispensary equipment used in the preparation of therapeutic goods                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                |\n| 8                | the following goods, unless the goods are for the treatment, cure, prevention, diagnosis or monitoring of, or testing susceptibility of persons to, a disease, condition, ailment or defect:(a) homoeopathic preparations more dilute than a one thousand fold dilution of a mother tincture and which are not required to be sterile;and which do not include an ingredient of:(i) human origin; or(ii) animal origin, if the ingredient consists of, or is derived from, any of the following parts of cattle, sheep, goats or mule deer:(A) adrenal;(B) brain;(C) cerebrospinal fluid;(D) dura mater;(E) eye;(F) ileum;(G) lymph nodes;(H) pineal gland;                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    |\n|                  | (I) pituitary;(J) placenta;(K) proximal colon;(L) spinal cord;(M) spleen;(N) tonsil;(c) unmedicated anti‑acne preparations having only a cleansing action or purpose;(d) medicated insect repellents for dermal use if the medication consists solely of an antiseptic having a secondary role in the formulation, except those that are included in a Schedule to the Poisons Standard;(f) disinfectants, except those described in item 16 in Schedule 4                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     |\n| 8A               | Lotions, shampoos or hairdressings for the prevention or treatment of dandruff, except those that:(a) are included in a Schedule to the Poisons Standard; or(b) are also for the treatment, cure, prevention, diagnosis or monitoring of, or testing susceptibility of persons to, another disease, condition, ailment or defect                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               |\n| 8B               | unmedicated preparations for topical use for protecting against, or providing relief from, nappy rash symptoms by acting only as a barrier for the skin (whether or not the preparations also have a moisturising action)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      |\n| 9                | Starting materials that are ingredients or components for use in the manufacture of therapeutic goods, except when:(a) prepackaged for supply for other therapeutic purposes; or(b) formulated as a dosage form; or(c) the starting materials are nicotine in solution imported for use as an ingredient in a therapeutic good; or(d) the starting materials are ingredients or components imported for use in the manufacture of:(i) a therapeutic vaping substance; or(ii) a therapeutic vaping substance accessory                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          |\n| 10               | medicines that are blood and blood components manufactured by the holder of a licence to manufacture blood and blood components                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                |\n| 11               | therapeutic goods:(a) in relation to the importation of which a permission, licence or declaration under regulation 5A, 5B or 5C of the Customs (Prohibited Imports) Regulations 1956 granted or made before the commencement of the Act is in force; and(b) which are supplied in Australia for use in humans not more than 6 months after the commencement of the Act                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        |\n| 12               | allergens for skin patch testing on unbroken skin, whether or not the allergen is also described in an item in Schedule 3 or 4                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 |\n| 13               | radiopharmaceutical cold kits that are:(a) containers of sterile reagents to which radioisotope is added immediately before injection into patients; and(b) manufactured by a radiochemist or a pharmacist in a public or private hospital for subsequent extemporaneous compounding and dispensing for use by, or in connection with:(i) a patient of that hospital; or(ii) a patient of another public or private hospital in the same State or Territory                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    |\n| 14               | (a) tampons; and(b) menstrual cups                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             |\n\n","sortOrder":3},{"sectionNumber":"Sch 5A","sectionType":"schedule","heading":"Therapeutic goods exempt from operation of Parts 3‑2 and 3‑2A of Act subject to conditions","content":"Schedule 5A—Therapeutic goods exempt from operation of Parts 3‑2 and 3‑2A of Act subject to conditions\n\n(subregulations 12(2) and (3))\n\n| Column 1Item | Column 2Therapeutic goods                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  | Column 3Conditions                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             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|\n| 1            | Therapeutic goods imported into Australia, if:(a) the goods are not any of the following:(i) disposable therapeutic vapes (other than disposable therapeutic vapes that are, or include, medicinal cannabis products);(ii) therapeutic vaping substances (other than therapeutic vaping substances that are medicinal cannabis products);(iii) therapeutic vaping substance accessories (other than therapeutic vaping substance accessories that are, or include, medicinal cannabis products);(iv) a therapeutic vaping kit (other than a therapeutic vaping kit where each good in the kit is, or includes, a medicinal cannabis product);(v) goods in a therapeutic vaping pack; and(b) the goods are held under the direct control of the sponsor, until the goods are:(i) the subject of a notification under item 3; or(ii) approved for importation into Australia under subsection 19(1), section 19A, subsection 32CK(1) or section 32CO of the Act; or(iii) authorised for supply under subsection 19(5) or 32CM(1) of the Act; or(iv) authorised for supply under rules made under subsection 19(7A) or 32CM(7A) of the Act; or(v) dispensed as a medicine or biological prescribed for a Category A patient within the meaning of subregulation 12A(5); or(vi) exported from Australia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        | (a) the supply of the goods must be in accordance with the relevant notification, approval, authorisation or prescription; and(b) the goods must be kept in a warehouse or a properly secured area under the control of the sponsor; and(c) the sponsor must:(i) keep records relating to the source and supply of the goods; and(ii) if requested by the Secretary, give the records to the Secretary                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           |\n| 1A           | Therapeutic goods imported into Australia and held under the direct control of the sponsor, until a decision is made under section 25, 26, 26A, 26AE, 32DB, 32DC, 32DF or 32DG of the Act about the goods                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  | (a) the sponsor must:(i) keep records about the source of the goods; and(ii) if requested by the Secretary, give the records to the Secretary; and(iii) have lodged an application under section 23, 32DA or 32DD of the Act for the goods before their importation; and(b) if the goods are not registered, listed, or included in the Register under Part 3‑2A of the Act:(i) in the case of therapeutic goods other than biologicals—the goods must be destroyed; or(ii) in the case of biologicals—the biologicals must be destroyed or returned to the consignor of the biologicals within 1 month of the decision not to include the biologicals                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           |\n| 1B           | Therapeutic goods imported into Australia that are needed for dispensing as a medicine prescribed for persons who are seriously ill with a condition from which premature death is reasonably likely to occur in the absence of early treatment                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            | (a) the goods must be supplied to a person covered by column 2 in circumstances where subparagraphs 12A(2)(a)(ii) and (iii) and paragraph 12A(2)(b) of these Regulations are satisfied; and(b) until the goods need to be so supplied, either or both of the following apply:(i) the goods are kept in a warehouse or a properly secured area under the control of the sponsor;(ii) the goods are kept at a hospital or other healthcare facility after being delivered to the hospital or facility by, or on behalf of, the sponsor; and(c) the sponsor must:(i) keep records relating to the source, and delivery, of the goods; and(ii) if requested by the Secretary, give the records to the Secretary                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      |\n| 2            | Therapeutic goods that are medicinal cannabis products manufactured in Australia under a licence granted under Part 3‑3 of the Act and are held under the direct control of the sponsor, until the goods are:(a) the subject of a notification under item 3; or(b) approved for supply in Australia under subsection 19(1) or section 19A of the Act; or(c) authorised for supply under subsection 19(5) of the Act; or(d) authorised for supply under rules made under subsection 19(7A) of the Act                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       | (a) the supply of the goods must be in accordance with the relevant notification, approval or authorisation; and(b) the goods must be kept in a warehouse or a properly secured area under the control of the sponsor; and(c) the sponsor must:(i) keep records relating to the source and supply of the goods; and(ii) if requested by the Secretary, give the records to the Secretary                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         |\n| 2A           | Therapeutic goods that are medicinal cannabis products manufactured in Australia under a licence granted under Part 3‑3 of the Act and are held under the direct control of the sponsor, until a decision is made under section 25 or 26 of the Act about the goods                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        | the sponsor must:(a) keep records about the source of the goods; and(b) if requested by the Secretary, give the records to the Secretary; and(c) have lodged an application under section 23 of the Act for the goods before their manufacture                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   |\n| 3            | Therapeutic goods to be used in a clinical trial solely for experimental purposes in humans                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                | (a) the sponsor must notify the Secretary:(i) in a form approved by the Secretary; and(ii) in accordance with the requirements (if any) determined by the Secretary for the form of notification;about the trial and the therapeutic goods covered by the trial and must do so before:(iii) the goods begin to be used in the trial, unless subparagraph (iv) applies; or(iv) if the sponsor seeks the Secretary’s agreement to the notification being given before the end of a period nominated by the sponsor and the Secretary agrees to this—the end of that nominated period; andthat the sponsor intends to sponsor a clinical trial using specified goods; and(b) the notification referred to in paragraph (a) must be accompanied by the relevant notification fee referred to in paragraph (a) of column 2 of item 14 in the table in clause 3 of Schedule 9 or paragraph (a) of the column headed “Matter” in item 17 of the table in Part 2 of Schedule 9A; and                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     |\n|              |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            | (c) the approval of the goods for this purpose must be given by the sponsor (if the sponsor is conducting the trial), or by the body or organisation conducting the trial for the sponsor, having regard to the advice of the ethics committee that has, or will assume, responsibility for monitoring the conduct of the trial; and(d) the terms of the approval by the sponsor, body or organisation referred to in paragraph (c) must be no less restrictive than the terms advised by the ethics committee; and(e) the Secretary must not, at any time:(i) have become aware that to conduct or continue the trial would be contrary to the public interest; and(ii) have directed that the trial not be conducted, or be stopped; and                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       |\n|              |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            | (f) the sponsor (if the sponsor is conducting the trial), or the body or organisation conducting the trial for the sponsor, must not receive, or have received, advice from the ethics committee that is inconsistent with the continuation of the trial; and(g) the conditions set out in regulation 12AD must be complied with, as if that regulation applied to a person using therapeutic goods under this item; and(h) the goods are not either or both of the following:(i) a Class 4 biological that has not received clinical trial approval for an equivalent indication from a national regulatory agency with comparable regulatory requirements;(ii) a Class 4 biological that does not have a history of previous usage that is supported by clinical evidence received by the TGA; and(ha) the sponsor must notify the Secretary:(i) in a form approved by the Secretary; and(ii) in accordance with the requirements (if any) determined by the Secretary for the form of notification;about any trial site not covered by the notification referred to in paragraph (a) and must do so before:(iii) the goods begin to be used at that site, unless subparagraph (iv) applies; or(iv) if the sponsor seeks the Secretary’s agreement to the notification being given before the end of a period nominated by the sponsor and the Secretary agrees to this—the end of that nominated period; and(hb) the notification referred to in paragraph (ha) must be accompanied by the relevant notification fee referred to in paragraph (b) of column 2 of item 14 in the table in clause 3 of Schedule 9 or paragraph (b) of the column headed “Matter” in item 17 of the table in Part 2 of Schedule 9A; and(i) the sponsor must comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial (whether or not the sponsor is conducting the trial); and(j) if a body or organisation is conducting the trial for the sponsor, that body or organisation must comply with requests by an authorised officer, whether made before or after the start of the trial, to give information about the conduct of the trial; and(k) the sponsor (if the sponsor is conducting the trial), or the body or organisation conducting the trial for the sponsor, must allow an authorised officer to do the things mentioned in regulation 12AC                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          |\n| 4            | Therapeutic goods that are imported by a member of a group of persons                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      | (a) the group must be visiting Australia to participate in a national or an international sporting event; and(b) the goods must be for use in the treatment of a member or members of that group; and(c) the importation of the goods must not be prohibited under the Customs (Prohibited Imports) Regulations 1956; and(d) the goods must not be supplied to, or used in the treatment of, a person who is not a member of the visiting group; and(e) any portion of the goods that is unused at the end of the visit must be destroyed or removed from Australia; and(f) a member of the group must be responsible for the control and custody of the goods while the group is in Australia; and(g) the person referred to in paragraph (f) must:(i) carry a list, in English, of the quantity and nature of the therapeutic goods imported; and(ii) for each of the goods that is not a biological—include in the list the generic name and strength of the active ingredient of the goods; and(iii) keep a record of the use of the goods while the group is in Australia; and(iv) produce the list or the record for inspection at the request of a customs officer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        |\n| 5            | Therapeutic goods, if:(a) the goods are not:(i) biologicals; or(ii) goods referred to in item 3; and(b) the goods are manufactured by a person under a contract between the person and a private hospital, a public hospital in a State or Territory or a public institution (the relevant institution); and(c) the manufacture is in accordance with a formulation specified by the relevant institution; and(d) the goods are for use by, or in connection with, a patient of:(i) the relevant institution; or(ii) if the relevant institution is a public hospital in a State or Territory—another public hospital in the State or Territory                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            | (a) there are no listed goods or registered goods that, in all relevant respects, are substantially similar to the goods; and(b) the person:(i) manufactures the goods at premises in Australia; and(ii) holds a licence, required by the Act, that authorises the manufacture, or a step in the manufacture, of the goods at those premises; and(c) the person notifies the Secretary, in accordance with a form approved by the Secretary and within 15 days of the end of a quarter, of:(i) the goods manufactured under the contract during that quarter; and(ii) the relevant institution that entered the contract                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         |\n| 7            | Therapeutic goods, or parts of therapeutic goods, that form part of a medicine delivery system in which the medicine is supplied in a device that acts as a container                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      | (a) none of the goods, or any part of the goods are separately supplied in Australia; and(b) if the component and kit manufacturer are the same manufacturer and the components are not separately supplied outside the kit by the kit sponsor; and(c) if the kit sponsor or the manufacturer obtains components from other manufacturers and the kit manufacturer’s licence covers quality control of those components                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          |\n| 8            | Therapeutic goods imported by a member of a group of persons                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               | (a) the group must be members of the military forces of another country, visiting Australia for military training; and(b) the goods must be for use in the treatment of a member or members of that group; and(c) the goods must not be supplied to, or used in the treatment of, a person other than a member of:(i) the visiting group; or(ii) the Australian Defence Force; and(d) any portion of the goods that is unused at the end of the visit must be destroyed or removed from Australia; and(e) a member of the group to whom the goods have been issued must be responsible for the control and custody of the goods while the group is in Australia; and(f) the person mentioned in paragraph (e) must:(i) carry a list, in English, of the quantity and nature of the therapeutic goods imported; and(ii) for each of the goods that is not a biological—include in the list the generic name and strength of the active ingredient of the goods; and(iii) keep a record of the use of the goods while the group is in Australia; and(iv) produce the list or the record for inspection at the request of a customs officer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         |\n| 9            | Unused emergency goods or unused emergency biologicals directed by the Secretary, under clause 7 of Schedule 5B, to be exported                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            | the provisions of Schedule 5B continue to apply to the goods or biologicals, as if the goods or biologicals were not exempt from the operation of section 30G or 32CG of the Act                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 |\n| 10           | Therapeutic goods imported into Australia by a medical practitioner or a member of a medical team (being 1 or more persons under the professional supervision of a medical practitioner)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   | (a) the medical practitioner or medical team must be accompanying a person to Australia who:(i) has a critical illness; and(ii) is under the direct care and supervision of the practitioner or team; and(b) the goods must be for use in the treatment of the person who has the critical illness; and(c) the importation of the goods must not be prohibited under the Customs (Prohibited Imports) Regulations 1956; and(d) the quantity of the goods must be consistent with the quantity required for the treatment of the person mentioned in paragraph (b); and(e) the goods must not be supplied to, or used in the treatment of, a person other than the person mentioned in paragraph (b); and(f) any portion of the goods that is unused at the end of the visit must be destroyed or removed from Australia; and(g) the medical practitioner, or a member of the medical team, must be responsible for the control and custody of the goods while the practitioner or team is in Australia; and(h) the person mentioned in paragraph (g) must:(i) carry a list, in English, of the quantity and nature of the therapeutic goods imported; and(ii) for each of the goods that is not a biological—include in the list the generic name and strength of the active ingredient of the goods; and(iii) keep a record of the use of the goods while the medical practitioner or medical team is in Australia; and                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         |\n|              |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            | (iv) produce the list or record for inspection at the request of a customs officer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               |\n| 11           | Therapeutic goods imported into Australia by a member of a group of persons                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                | (a) the group must include a person who is the Head of State or Head of Government of a foreign country and senior Government officials of that country, who are visiting Australia on official business; and(b) the goods must be for use in the treatment of a member or members of the visiting group; and(c) the importation of the goods must not be prohibited under the Customs (Prohibited Imports) Regulations 1956; and(d) the goods must not be supplied to, or used in the treatment of, a person other than a member of the visiting group; and(e) any portion of the goods that is unused at the end of the visit must be destroyed or removed from Australia; and(f) a member of the visiting group must be responsible for the control and custody of the goods while the group is in Australia; and(g) the person mentioned in paragraph (f) must:(i) carry a list, in English, of the quantity and nature of the therapeutic goods imported; and(ii) for each of the goods that is not a biological—include in the list the generic name and strength of the active ingredient of the goods; and(iii) keep a record of the use of the goods while the group is in Australia; and                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               |\n|              |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            | (iv) produce the list or record for inspection at the request of a customs officer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               |\n| 12           | Therapeutic goods that are part of the medical supplies of a ship (including a yacht or other marine vessel) or aircraft visiting Australia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                | (a) the goods must be for use in the treatment of a passenger or a member of the crew travelling on the ship or aircraft; and(b) the importation of the goods must not be prohibited under the Customs (Prohibited Imports) Regulations 1956; and(c) the quantity of the goods must be consistent with the quantity required for the treatment of passengers and members of the crew travelling on the ship or aircraft; and(d) the goods must not be supplied to, or used in the treatment of, a person other than a passenger or a member of the crew travelling on the ship or aircraft; and(e) the goods must not be removed from the ship or aircraft while the ship or aircraft is in Australia; and(f) the master of the ship or the pilot of the aircraft must be responsible for the control and custody of the goods while the ship or aircraft is in Australia; and(g) the person mentioned in paragraph (f) must:(i) carry a list, in English, of the quantity and nature of the therapeutic goods imported; and(ii) for each of the goods that is not a biological—include in the list the generic name and strength of the active ingredient of the goods; and(iii) keep a record of the use of the goods while the ship or aircraft is in Australia; and                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          |\n|              |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            | (iv) produce the list or record for inspection at the request of a customs officer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               |\n| 13           | Therapeutic goods in relation to which all of the following paragraphs apply:(a) the goods comprise, contain or are derived from human cells or human tissues collected from a patient who is under the clinical care of a medical or dental practitioner;(b) the goods were manufactured by, or under the professional supervision of, the practitioner;(c) the single indication of the goods is homologous use:(i) on that patient; and(ii) in a single clinical procedure; and(iii) by, or under the professional supervision of, that practitioner;(d) the goods have been subjected to only minimal manipulation;(e) the practitioner is registered in a State or internal Territory                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 | if the sponsor knows that particular information relating to an event or occurrence indicates that use of the goods as intended by the sponsor may have an unintended harmful effect, the sponsor must give the information to the Secretary within the period specified by regulation 16AB                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      |\n| 14           | Therapeutic goods in packs, if:(a) the packs contain tampons or menstrual cups; and(b) any other therapeutic goods in the packs are included in the Register; and(c) the packaging of any individually packaged medical devices or medicines in the pack is intact; and(d) the packs do not contain any of the following:(i) a biological;(ii) a medicine mentioned in Part 1 of Schedule 10;(iii) a medical device (other than an IVD medical device) that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class IIa or higher;(iv) an IVD medical device or in‑house IVD medical device that is classified under the Therapeutic Goods (Medical Devices) Regulations 2002 as Class 2 or higher                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           | the packs must not be supplied:(a) by persons other than charities; or(b) for a charge; or(c) to persons other than homeless or disadvantaged women                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              |\n| 15           | Therapeutic goods, if:(a) the goods are:(i) therapeutic vaping substances; or(ii) therapeutic vaping substance accessories; or(iii) a therapeutic vaping kit; or(iv) goods in a therapeutic vaping pack; and(b) the goods are not, or do not include, any medicinal cannabis products; and(c) the only indications of the goods are use for smoking cessation or the management of nicotine dependence; and(d) for goods other than therapeutic vaping devices, or therapeutic vaping device accessories, in a therapeutic vaping pack—the sponsor of the goods, and any other person involved in the wholesale or retail supply of the goods, intend the goods to be supplied to the ultimate consumer of the goods in accordance with an approval or authority under section 19 of the Act; and(e) the sponsor has given the Secretary a notice (the sponsor notice) stating that:(i) the goods conform with each standard (as in force from time to time) that is applicable to the goods, or are imported or supplied (as the case may be) with the consent of the Secretary under section 14 or 14A of the Act; and(ii) the only indications of the goods are use for smoking cessation or the management of nicotine dependence; and(f) the sponsor notice has not been withdrawn by the sponsor by a notice (the withdrawal notice) given to the Secretary, with the withdrawal taking effect:(i) on the day specified in the withdrawal notice, being a day that is later than the day that notice is given to the Secretary; or(ii) otherwise—on the day the withdrawal notice is given; and(g) the goods are not the subject of a determination, by the Secretary and published on the Department’s website, that the supply of the goods be stopped or should cease because:(i) the Secretary is satisfied that the supply compromises public health and safety; or(ii) the Secretary is satisfied that the goods do not conform with a standard applicable to the goods; or(iii) the sponsor has failed to comply with a request by the Secretary under paragraph (e) of column 3 of this item | (a) the sponsor must give the sponsor notice to the Secretary in a form approved in writing by the Secretary; and(b) the sponsor notice must be given as follows:(i) for goods imported into Australia on or after 1 March 2024—before the goods are imported;(ii) for goods imported into Australia before 1 March 2024—before the earlier of the time the goods are supplied to the ultimate consumer and the end of the period of 2 months beginning on the day Schedule 1 to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024 commences; and(iii) for goods manufactured in Australia on or after 1 March 2024—before the goods are first supplied in Australia; and(iv) for goods manufactured in Australia before 1 March 2024—before the earlier of the time the goods are supplied to the ultimate consumer and the end of the period of 2 months beginning on the day Schedule 1 to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024 commences; and(c) the sponsor holds information or evidence to support:(i) the statement made in the sponsor notice under subparagraph (e)(ii) of column 2 of this item; and(ii) if the sponsor has not given a notice under paragraph (e) of this column of this item—the statement made in the sponsor notice under subparagraph (e)(i) of column 2 of this item; and(iii) if the sponsor has given one or more notices under paragraph (e) of this column of this item—the statement made in the most recent of those notices;including, in relation to a statement that the goods conform with each standard (as in force from time to time) that is applicable to the goods, to demonstrate that the goods continue to so conform; and(d) the following statements are, and continue to be, correct:(i) the statement made in the sponsor notice under subparagraph (e)(ii) of column 2 of this item;(ii) if the sponsor has not given a notice under paragraph (e) of this column of this item—the statement made in the sponsor notice under subparagraph (e)(i) of column 2 of this item;(iii) if the sponsor has given one or more notices under paragraph (e) of this column of this item—the statement made in the most recent of those notices;including, in relation to a statement that the goods conform with each standard (as in force from time to time) that is applicable to the goods, that the goods continue to so conform; and(e) the sponsor must:(i) if requested by the Secretary, give the Secretary a notice, in a form approved in writing by the Secretary, stating either that the goods conform with each standard (as in force from time to time) that is applicable to the goods or that the goods are being imported or supplied (as the case may be) with the consent of the Secretary under section 14 or 14A of the Act; and(ii) do so within the period requested by the Secretary (which must be at least 5 working days starting on the day on which the Secretary’s request is made); and(f) the sponsor must:(i) if requested by the Secretary, give the Secretary the information or evidence referred to in paragraph (c); and(ii) do so within the period requested by the Secretary (which must be at least 5 working days starting on the day on which the Secretary’s request is made); and(fa) the sponsor must:(i) if requested by the Secretary, give the Secretary a reasonable number of samples of the goods; and(ii) do so within the period requested by the Secretary (which must be at least 5 working days starting on the day on which the Secretary’s request is made); and(fb) the sponsor must allow an authorised officer:(i) to enter, at any reasonable time, any premises (including premises outside Australia) at which the sponsor or any other person deals with the goods; and(ii) while on those premises, to inspect those premises and the goods and to examine, take measurements of, conduct tests on, require tests to be conducted on or take samples of the goods or any thing on those premises that relates to the goods; and(iii) while on those premises, to make any still or moving image or any recording of those premises or any thing on those premises; and(fc) the sponsor must, if requested to do so by an authorised officer, produce to the authorised officer such documents relating to the goods as the authorised officer requires and allow the authorised officer to copy the documents; and(fd) if the sponsor is not the manufacturer of the goods, the sponsor must have procedures in place to ensure that the manufacturer of the goods allows an authorised officer:(i) to enter, at any reasonable time, any premises (including premises outside Australia) at which the manufacturer or any other person deals with the goods; and(ii) while on those premises, to inspect those premises and the goods and to examine, take measurements of, conduct tests on, require tests to be conducted on or take samples of the goods or any thing on those premises that relates to the goods; and(iii) while on those premises, to make any still or moving image or any recording of those premises or any thing on those premises; and(fe) if the sponsor is not the manufacturer of the goods, the sponsor must have procedures in place to ensure that the manufacturer of the goods, if the manufacturer is requested to do so by an authorised officer, produces to the authorised officer such documents relating to the goods as the authorised officer requires and allow the authorised officer to copy the documents; and(g) for goods manufactured in Australia—either of the following apply:(i) the goods are manufactured by a person who is the holder of a licence in force under Part 3‑3 of the Act that authorises the manufacture of the goods, or the carrying out of the step in the manufacture of the goods, at the manufacturing site where the manufacture, or the step, is carried out;(ii) the goods are manufactured by a person who is exempt in accordance with subsection 34(2) of the Act from the operation of Part 3‑3 of the Act in relation to the manufacture of the goods and the Secretary has given the person a consent under subsection 41RC(1) of the Act to manufacture the goods, or carry out the step in the manufacture of the goods, and the manufacture, or the step, is carried out in accordance with the consent; and(h) the goods may be supplied to a person who is not the ultimate consumer of the goods only if:(i) the person (the recipient) to whom the goods are supplied is the holder of a licence in force under Part 3‑3 of the Act that authorises a step in the manufacture of the goods; or(ii) the recipient is a wholesaler, pharmacist, medical practitioner or nurse practitioner who is the holder of a licence, or is otherwise authorised, to supply one or more substances included in Schedule 3 to the current Poisons Standard under a law of the State or Territory in which the recipient carries on a business, practises or is employed; or(iii) the Secretary has given the recipient a consent under subsection 41RC(1) of the Act to supply the goods; or(iv) in the case of goods that are covered by a determination made by the Minister under section 41R of the Act—the recipient is specified in the determination, or is included in a class of persons specified in the determination, in relation to those goods; and(i) the goods may be supplied to the ultimate consumer of the goods only if:(i) the goods are supplied as a finished product; and(ii) the supply is by a pharmacist, medical practitioner or nurse practitioner who is the holder of a licence, or is otherwise authorised, to supply one or more substances included in Schedule 3 to the current Poisons Standard under a law of the State or Territory in which the recipient carries on a business, practises or is employed; and(iii) for goods other than therapeutic vaping devices, or therapeutic vaping device accessories, in a therapeutic vaping pack—the supply is in accordance with an approval or authority under section 19 of the Act; and(iv) if the supply is by a person authorised as described in subparagraph (ii), the supply is in accordance with that authorisation; and(j) the sponsor must:(i) keep records relating to the source and supply of the goods; and(ii) if requested by the Secretary, give a copy of the records to the Secretary within the period requested by the Secretary (which must be at least 5 working days starting on the day on which the Secretary’s request is made); and(iii) if the Secretary requests information about the supply of the goods during a specified period—give the information to the Secretary within the period requested by the Secretary (which must be at least 5 working days starting on the day on which the Secretary’s request is made) and in a form approved in writing by the Secretary; and(k) the sponsor must provide information of a kind mentioned in subsection 29A(2) or 29AA(2) of the Act relating to the goods to the Secretary within the following periods:(i) if the information relates to an event or other occurrence that represents a serious threat to public health—48 hours after the sponsor becomes aware of the event or occurrence;(ii) if the information relates to an event or other occurrence that led to the death, or a serious deterioration in the state of health, of a patient, a user of the goods, or another person—10 days after the sponsor becomes aware of the event or occurrence;(iii) if the information relates to an event or other occurrence a recurrence of which might lead to the death, or a serious deterioration in the state of health, of a patient, a user of the goods, or another person—30 days after the sponsor becomes aware of the event or occurrence;(iv) in any other case—60 days after the sponsor becomes aware of the information |\n| 16           | Therapeutic goods imported into Australia, if:(a) the goods are nicotine in solution as a starting material for use in the manufacture of a therapeutic vaping substance, a therapeutic vaping substance accessory or any other therapeutic good; or(b) the goods are any other starting materials that are ingredients or components for use in the manufacture of a therapeutic vaping substance or a therapeutic vaping substance accessory                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             | (a) the sponsor must give the Secretary a notice (the sponsor notice), in a form approved in writing by the Secretary, stating that the goods are for use in the manufacture, in accordance with the requirements of the Act, of another therapeutic good by a manufacturer that holds all relevant licences or approvals (however described) required under the following:(i) Part 3‑3 of the Act;(ii) the law of the State or Territory in which the manufacture is to occur; and(b) the sponsor notice must be given before importing the goods; and(ba) the sponsor must:(i) if requested by the Secretary, give the Secretary a reasonable number of samples of the goods; and(ii) do so within the period requested by the Secretary (which must be at least 5 working days starting on the day on which the Secretary’s request is made); and(c) the goods may be supplied only for use in manufacture as referred to in paragraph (a)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    |\n\n## 1 Early end of exemption—notice of goods held\n\n#### 1 Early end of exemption—notice of goods held\n\n  (1) This clause applies if:\n    (a) the Minister makes an exemption under subsection 18A(1) of the Act in relation to specified therapeutic goods or therapeutic goods in a specified class; and\n    (b) a person is given a copy of a revocation or variation of the exemption under paragraph 18A(9B)(b) of the Act.\n  (2) The person must give the Secretary:\n    (a) notice, in writing, of the quantity and location of:\n    (i) for a revocation—the goods over which the person has control that have not been used; or\n    (ii) for a variation—the goods mentioned in the variation over which the person has control that have not been used; and\n    (b) a copy of any records about the goods that the person is required to keep under a condition of the exemption.\n  (3) The person must comply with subclause (2) in relation to the goods within 7 days after the day the exemption ends for the goods.\n\n## 1A Early cessation of exemption—notice of biologicals held\n\n#### 1A Early cessation of exemption—notice of biologicals held\n\n  (1) A person who is given notice under paragraph 32CE(b) of the Act must give to the Secretary:\n    (a) notice, in writing, of the quantity and location of any unused emergency biologicals over which the person has control; and\n    (b) a copy of any records about the biologicals that, under a condition of the exemption, the person is required to keep.\n  (2) Subclause (1) must be complied with:\n    (a) if the notice under paragraph 32CE(b) of the Act is given before the exemption ceases to have effect for the biologicals—within 7 days after the exemption ceases; or\n    (b) in any other case—within 7 days after the notice is given.\n\n## 2 Expiration of period of exemption—notice of goods held\n\n#### 2 Expiration of period of exemption—notice of goods held\n\n  A person who has been importing, manufacturing, supplying or exporting therapeutic goods under an exemption under subsection 18A(1) of the Act must, within 7 days after the exemption ceases to have effect under paragraph 18A(4)(a) of the Act, give to the Secretary:\n    (a) notice, in writing, of the quantity and location of any unused emergency goods over which the person has control; and\n    (b) a copy of any records about the goods that, under a condition of the exemption, the person is required to keep.\n\n## 2A Expiration of period of exemption—notice of biologicals held\n\n#### 2A Expiration of period of exemption—notice of biologicals held\n\n  A person who has been importing, manufacturing, supplying or exporting biologicals under an exemption under subsection 32CB(1) of the Act must, within 7 days after the end of the period specified in the exemption under subsection 32CB(4), give to the Secretary:\n    (a) notice, in writing, of the quantity and location of any unused emergency biologicals over which the person has control; and\n    (b) a copy of any records about the biologicals that, under a condition of the exemption, the person is required to keep.\n\n## 3 Storage and disposal of unused emergency goods and unused emergency biologicals\n\n#### 3 Storage and disposal of unused emergency goods and unused emergency biologicals\n\n  (1) A person who has control over unused emergency goods or unused emergency biologicals must ensure that those unused emergency goods or unused emergency biologicals are stored in a way that ensures that:\n    (a) the goods or biologicals are only accessible for supply, export, use or disposal in accordance with the Act and these Regulations; and\n    (b) the security of the goods or biologicals is appropriate to the level of risk that the goods or biologicals could pose to the public and the environment; and\n    (c) the integrity of the condition of the goods or biologicals is maintained.\n  (2) A person may dispose of unused emergency goods or unused emergency biologicals only in accordance with a direction given by the Secretary under subclause 4(1).\n\n## 4 Direction for disposal of unused emergency goods and unused emergency biologicals\n\n#### 4 Direction for disposal of unused emergency goods and unused emergency biologicals\n\n  (1) The Secretary may direct, in writing, any person who has control over unused emergency goods or unused emergency biologicals to dispose of the unused emergency goods or unused emergency biologicals in the manner directed.\n  (2) A direction given under subclause (1) must be in accordance with clause 5, 6, 7 or 8.\n  (3) A person who has been given a direction under subclause (1) must comply with the direction.\n\n## 5 Relocation of unused emergency goods and unused emergency biologicals\n\n#### 5 Relocation of unused emergency goods and unused emergency biologicals\n\n  If storage of particular unused emergency goods or unused emergency biologicals at a particular location poses, or would pose, a risk to the public or the environment, the Secretary may direct that the goods or biologicals be stored at a specified location that will ensure compliance with subclause 3(1).\n\n## 6 Disposal of unused emergency goods and unused emergency biologicals—destruction\n\n#### 6 Disposal of unused emergency goods and unused emergency biologicals—destruction\n\n  (1) The Secretary may direct that unused emergency goods or unused emergency biologicals be destroyed within the time specified in the direction if any of the following applies:\n    (a) the goods or biologicals have passed their expiry date;\n    (b) the goods or biologicals no longer conform to a standard that applies to the goods or biologicals;\n    (c) use of the goods or biologicals poses, or would pose, a risk to public health;\n    (d) storage of the goods or biologicals at their current location and any other location poses, or would pose, a risk to the public or the environment;\n    (e) for unused emergency goods—within 12 months after the exemption ceases to have effect in relation to the goods, the goods have not become (whether in relation to an indication for which the goods could have been used under the exemption or in relation to a different indication):\n    (iv) goods that are the subject of an approval under section 19A of the Act;\n    (ea) for unused emergency biologicals—within 12 months after the exemption ceases to have effect in relation to the biologicals, the biologicals have not become (whether in relation to an indication for which the biologicals could have been used under the exemption or in relation to a different indication):\n    (ii) exempt biologicals under section 32CA of the Act; or\n    (iii) biologicals that are the subject of an approval or authority under section 32CK or 32CM of the Act; or\n    (iv) biologicals that are the subject of an approval under section 32CO of the Act;\n    (f) the person who has control over the goods or biologicals requests that the goods or biologicals be destroyed.\n  (2) A person directed to destroy the goods or biologicals may destroy the goods or biologicals only in a way, approved by the Secretary, that ensures that the destruction avoids or minimises harm to the public and the environment.\n\n## 7 Disposal of unused emergency goods and unused emergency biologicals—export\n\n#### 7 Disposal of unused emergency goods and unused emergency biologicals—export\n\n  (1) This clause applies to unused emergency goods or unused emergency biologicals to which any of paragraphs 6(1)(a) to (e) applies.\n  (2) The Secretary may direct that the goods or biologicals be exported to a country, instead of directing that they be destroyed, if a relevant authority of the country has confirmed, in writing or by electronic communication, its willingness to accept the goods or biologicals.\n  (3) A person directed to export the goods or biologicals must ensure that, during exportation:\n    (a) the goods or biologicals are only accessible for purposes relating to the export; and\n    (b) the security of the goods or biologicals is appropriate to the level of risk that the goods or biologicals could pose to the public and the environment; and\n    (c) the integrity of the condition of the goods or biologicals is maintained.\n  (4) In this clause:\n\n> electronic communication has the meaning given by subsection 5(1) of the Electronic Transactions Act 1999.\n\n## 8 Disposal of unused emergency goods and unused emergency biologicals—supply\n\n#### 8 Disposal of unused emergency goods and unused emergency biologicals—supply\n\n  (1) This clause applies to unused emergency goods or unused emergency biologicals that have become (whether in relation to an indication for which the unused emergency goods or unused emergency biologicals could have been used under the exemption or in relation to a different indication):\n    (a) registered goods or listed goods; or\n    (aa) biologicals included in the Register under Part 3‑2A of the Act; or\n    (b) goods that are the subject of an approval or authority under section 19 of the Act; or\n    (ba) biologicals that are the subject of an approval or authority under section 32CK or 32CM of the Act; or\n    (c) goods that are the subject of an approval under section 19A of the Act; or\n    (d) biologicals that are the subject of an approval under section 32CO of the Act.\n  (2) The Secretary may direct that the goods or biologicals be supplied to an authorised person (otherwise than by way of administration to, or application in the treatment of, the person).\n  (3) In this clause:\n\n> authorised person means, as appropriate, a person:\n\n    (a) in relation to whom the registered goods or listed goods are registered or listed; or\n    (aa) in relation to whom the biologicals are included in the Register under Part 3‑2A of the Act; or\n    (b) to whom the approval under subsection 19(1) or section 32CK of the Act, or the authority under subsection 19(5) or 32CM(1) of the Act, is given; or\n    (ba) who is included in a class of health practitioners specified in rules made under subsection 19(7A) or 32CM(7A) of the Act; or\n    (c) to whom the approval under section 19A or 32CO of the Act is given.\n\n## 9 Owner to be paid for goods or biologicals supplied\n\n#### 9 Owner to be paid for goods or biologicals supplied\n\n  A direction given under clause 7 or 8 does not affect a person’s liability to pay the owner of the goods or biologicals for the export or supply of the goods or biologicals to the person.\n\n## 10 Records about unused emergency goods and unused emergency biologicals\n\n#### 10 Records about unused emergency goods and unused emergency biologicals\n\n  A person who has, or has had, control over unused emergency goods or unused emergency biologicals must:\n    (a) ensure that records are kept that include the following information:\n    (i) the quantities of the goods or biologicals under the person’s control;\n    (ii) how the goods or biologicals are stored before being disposed of;\n    (iii) if a direction under subclause 4(1) has been received—what actions have been taken to dispose of the goods or biologicals as directed and when the actions were taken;\n    (iv) if the goods or biologicals have been exported or supplied—to whom they were exported or supplied and in what quantity; and\n    (b) retain the records for 7 years after the last entry is made; and\n    (c) if the Secretary so requests in writing—give to the Secretary a copy of a record mentioned in paragraph (a):\n    (i) within 14 days after being notified of the Secretary’s request; or\n    (ii) if the information is required to establish whether the goods or biologicals pose imminent risk to the public or the environment—within 24 hours, or any shorter period, specified by the Secretary.\n\n## 11 Failure to comply with this Schedule\n\n#### 11 Failure to comply with this Schedule\n\n  If a person who has control over any unused emergency goods or unused emergency biologicals has not complied with a provision of this Schedule, the Secretary may direct, in writing, that the unused emergency goods or unused emergency biologicals be destroyed by another person.\n\n## Part 1 Interpretation\n\n## Part 1—Interpretation\n\n## 1 Definitions\n\n#### 1 Definitions\n\n  (1) In this table:\n\n> C1 (section 9D) application means a request made under subsection 9D(1), (2) or (3) of the Act to vary information included in an entry in the Register for a registered OTC medicine, that is made in accordance with a form, and in the manner, approved by the Secretary under subsection 9D(6) of the Act for a C1 (section 9D) application.\n\n> C1 (section 23) application means an application made under section 23 of the Act to register an OTC medicine that is made in accordance with the form, or in the manner, approved by the Secretary under paragraph 23B(2)(a) of the Act for a C1 (section 23) application.\n\n> C2 (section 9D) application means a request made under subsection 9D(3) of the Act to vary information included in an entry in the Register for a registered OTC medicine, that is made in accordance with a form, and in the manner, approved by the Secretary under subsection 9D(6) of the Act for a C2 (section 9D) application.\n\n> C2 (section 23) application means an application made under section 23 of the Act to register an OTC medicine that is made in accordance with the form, or in the manner, approved by the Secretary under paragraph 23B(2)(a) of the Act for a C2 (section 23) application.\n\n> C3 (section 9D) application means a request made under subsection 9D(3) of the Act to vary information included in an entry in the Register for a registered OTC medicine, that is made in accordance with a form, and in the manner, approved by the Secretary under subsection 9D(6) of the Act for a C3 (section 9D) application.\n\n> C3 (section 23) application means an application made under section 23 of the Act to register an OTC medicine that is made in accordance with the form, or in the manner, approved by the Secretary under paragraph 23B(2)(a) of the Act for a C3 (section 23) application.\n\n> C4 (section 9D) application means a request made under subsection 9D(3) of the Act to vary information included in an entry in the Register for a registered OTC medicine, that is made in accordance with a form, and in the manner, approved by the Secretary under subsection 9D(6) of the Act for a C4 (section 9D) application.\n\n> C4 (section 23) application means an application made under section 23 of the Act to register an OTC medicine that is made in accordance with the form, or in the manner, approved by the Secretary under paragraph 23B(2)(a) of the Act for a C4 (section 23) application.\n\n> haematopoietic progenitor cells means primitive pluripotent haematopoietic cells capable of self‑renewal as well as maturation into any of the haematopoietic lineages, including committed and lineage‑restricted progenitor cells.\n\n> major variation, for therapeutic goods of a particular kind, means a change to:\n\n    (a) the strength, as recorded in the entry in the Register; or\n    (b) the dosage, the recommended dose regimen or the maximum daily dose; or\n    (c) the dosage form; or\n    (d) the route of administration; or\n    (e) the intended patient group.\n\n> minor variation, for therapeutic goods of a particular kind, means a change (other than a change that is a major variation) to:\n\n    (a) the formulation, composition or design specification; or\n    (b) the container for the goods; or\n    (c) any other attribute of the goods that results in the goods being separate and distinct.\n\n> N1 application means an application made under section 23 of the Act to register an OTC medicine that is made in accordance with the form, or in the manner, approved by the Secretary under paragraph 23B(2)(a) of the Act for an N1 application.\n\n> N2 application means an application made under section 23 of the Act to register an OTC medicine that is made in accordance with the form, or in the manner, approved by the Secretary under paragraph 23B(2)(a) of the Act for an N2 application.\n\n> N3 application means an application made under section 23 of the Act to register an OTC medicine that is made in accordance with the form, or in the manner, approved by the Secretary under paragraph 23B(2)(a) of the Act for an N3 application.\n\n> N4 application means an application made under section 23 of the Act to register an OTC medicine that is made in accordance with the form, or in the manner, approved by the Secretary under paragraph 23B(2)(a) of the Act for an N4 application.\n\n> N5 application means an application made under section 23 of the Act to register an OTC medicine that is made in accordance with the form, or in the manner, approved by the Secretary under paragraph 23B(2)(a) of the Act for an N5 application.\n\n> new chemical entity means:\n\n    (a) a chemical, biological or radiopharmaceutical substance that has not previously been included in the Register; or\n    (b) an isomer, mixture of isomers, complex of, derivative of or salt of, a registered chemical substance that, having previously been included in the Register, differs from the registered substance in having different safety or efficacy properties; or\n    (c) a biological substance that, having previously been included in the Register, differs from the registered substance:\n    (i) in having a different molecular structure; or\n    (ii) in deriving from source material of a different nature or from a different manufacturing process; or\n    (d) a radiopharmaceutical substance that:\n    (i) is a radionucleide or ligand that has not previously been included in the Register; or\n    (ii) has a coupling mechanism, linking the molecule and radionucleide, that has not previously been included in the Register; or\n    (e) a fixed combination of active substances that have not previously been included in the Register as that fixed combination.\n\n> page means:\n\n    (a) a legible photocopy of 1 side of 1 leaf of a published work, diagram or chart; or\n    (b) in respect of any other work—1 side of 1 leaf (or a copy of 1 side of 1 leaf):\n    (i) that has a maximum length of 297 millimetres and a maximum width of 210 millimetres; and\n    (ii) that has a left‑hand margin that is at least 25 millimetres in width; and\n    (iii) the information on which is typed or printed in legible characters at least 8 points in size; and\n    (iv) that, if it is part of a document exceeding 1 page in length—is paginated.\n\n> primary site means the principal manufacturing premises in the capital city of each State and Territory where human blood and blood components are manufactured.\n\n  (2) For paragraph (a) of item 2A and items 2B, 2C, 2CA and 4 in Part 2, an application for registration, or variation of the registration, of therapeutic goods of a kind mentioned in Part 1 of Schedule 10 is taken to be a submission.\n  (3) A person making more than 1 application of a kind mentioned in subclause (2), simultaneously, is taken to be making a submission that includes all of those applications if the goods concerned contain the same active ingredient.\n\n## 2 Part 2 fees do not apply in relation to applications etc. covered by Part 3 or 4\n\n#### 2 Part 2 fees do not apply in relation to applications etc. covered by Part 3 or 4\n\n  The fees prescribed in Part 2 do not apply in relation to applications, evaluations and requests covered by Part 3 or 4.\n\n## Part 2 Table of fees other than for applications etc. covered by Part 3 or 4\n\n## Part 2—Table of fees other than for applications etc. covered by Part 3 or 4\n\n## 3 Table of fees\n\n#### 3 Table of fees\n\n  The following table sets out particular fees other than fees for applications, evaluations and requests covered by Part 3 or 4.\n\n| Column 1Item | Column 2Matter                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 | Column 3Fee $                                                                                                                                                                                                                               |\n| ------------ | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |\n| 1A           | Application fee for processing an application for consent under section 14 or 14A of the Act:                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  |                                                                                                                                                                                                                                             |\n|              | (a) for an application relating to goods to which a single entry in the Register relates                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       | 583 (for all the goods to which the application relates)                                                                                                                                                                                    |\n|              | (b) for an application relating to goods to which both of the following apply:(i) there are separate entries in the Register in relation to the goods;(ii) the way in which the goods do not conform with a standard applicable to the goods is the same for all the goods                                                                                                                                                                                                                                                                                                                                     | 583 for the first entry plus 117 for each additional entry                                                                                                                                                                                  |\n|              | (c) for an application relating to goods to which no entry in the Register relates                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             | 3,831                                                                                                                                                                                                                                       |\n| 1            | Evaluation fee for the purposes of subparagraph 19(2)(b)(iii) of the Act                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       |                                                                                                                                                                                                                                             |\n|              | (a) if:(i) the goods are medicines for use solely for experimental purposes in humans; and(ii) the evaluation consists of the consideration of:(A) a summary of chemical, pharmaceutical and biological information about the goods; and(B) descriptive information about the proposed clinical trial of the goods; and(C) information about adverse events associated with the use of the goods; and(D) information about the goods provided to the relevant ethics committee;—for each medicine                                                                                                              | 2,111                                                                                                                                                                                                                                       |\n|              | (b) if the goods are medicines for use solely for experimental purposes in humans (other than medicines to which paragraph (a) applies)—for each medicine                                                                                                                                                                                                                                                                                                                                                                                                                                                      | 26,240                                                                                                                                                                                                                                      |\n| 1AAA         | Fee for the purposes of paragraph 19(4B)(e) of the Act, for a request under subsection 19(4B) to vary the therapeutic goods specified in an approval to use those goods solely for experimental purposes in humans, or to vary the conditions of such an approval:                                                                                                                                                                                                                                                                                                                                             |                                                                                                                                                                                                                                             |\n|              | (a) if the request relates to:(i) goods that are medicines; and(ii) paragraph (a) of item 1 applied to the evaluation of the application for approval                                                                                                                                                                                                                                                                                                                                                                                                                                                          | 580                                                                                                                                                                                                                                         |\n|              | (b) if the request relates to:(i) goods that are medicines; and(ii) paragraph (b) of item 1 applied to the evaluation of the application for approval                                                                                                                                                                                                                                                                                                                                                                                                                                                          | 7,162                                                                                                                                                                                                                                       |\n| 1AA          | Application fee for the purposes of paragraph 22C(2)(b) of the Act for an application under subsection 22C(1) of the Act                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       | 15,279                                                                                                                                                                                                                                      |\n| 1AB          | Application fee for the purposes of paragraph 22E(4)(c) of the Act for an application under subsection 22E(3) of the Act                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       | 5,540                                                                                                                                                                                                                                       |\n| 1ABA         | Fee for the purposes of paragraph 22G(8)(b) of the Act for a request under section 22G of the Act                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              | 10,099                                                                                                                                                                                                                                      |\n| 1AC          | Application fee for the purposes of paragraph 23B(2)(b) of the Act for an application under section 23 of the Act for registration of a medicine in relation to which a provisional determination under section 22D of the Act is in force:                                                                                                                                                                                                                                                                                                                                                                    |                                                                                                                                                                                                                                             |\n|              | (a) if the application relates to a new prescription medicine                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  | 58,779                                                                                                                                                                                                                                      |\n|              | (b) if the application relates to a new indications medicine                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   | 35,105                                                                                                                                                                                                                                      |\n| 1AD          | Evaluation fee for the purposes of subsection 24(1A) of the Act for an application under section 23 of the Act for registration of a medicine in relation to which a provisional determination under section 22D of the Act is in force:                                                                                                                                                                                                                                                                                                                                                                       |                                                                                                                                                                                                                                             |\n|              | (a) if the evaluation relates to a new prescription medicine                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   | 306,723                                                                                                                                                                                                                                     |\n|              | (b) if the evaluation relates to a new indications medicine                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    | 202,344                                                                                                                                                                                                                                     |\n| 1AE          | Application fee for the purposes of paragraph 23B(2)(b) of the Act for an application under section 23 of the Act for registration of a medicine that is provisionally registered to be included in the part of the Register for goods known as registered goods                                                                                                                                                                                                                                                                                                                                               | 34,988                                                                                                                                                                                                                                      |\n| 1AF          | Evaluation fee for the purposes of subsection 24(1A) of the Act for an application under section 23 of the Act for registration of a medicine that is provisionally registered to be included in the part of the Register for goods known as registered goods                                                                                                                                                                                                                                                                                                                                                  | 147,530                                                                                                                                                                                                                                     |\n| 1AG          | Application fee for the purposes of paragraph 29(5)(d) of the Act for an application under subsection 29(4) of the Act                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         | 21,110                                                                                                                                                                                                                                      |\n| 1B           | Application fee for the purposes of paragraph 25AAA(3)(d) of the Act for therapeutic goods (priority applicant) determination in relation to a medicine                                                                                                                                                                                                                                                                                                                                                                                                                                                        | 15,279                                                                                                                                                                                                                                      |\n| 2            | Application fee for the purposes of paragraph 23B(2)(b) of the Act for registration of therapeutic goods (if regulation 43A does not apply):                                                                                                                                                                                                                                                                                                                                                                                                                                                                   |                                                                                                                                                                                                                                             |\n|              | (ba) for an application relating to a medicine in relation to which an evaluation fee is payable under paragraph (a) of item 4                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 | 58,663                                                                                                                                                                                                                                      |\n|              | (bb) for an application relating to a medicine in relation to which an evaluation fee is payable under subparagraph (aa)(i) or (ii) of item 4                                                                                                                                                                                                                                                                                                                                                                                                                                                                  | 19,476                                                                                                                                                                                                                                      |\n|              | (bc) for an application relating to a medicine in relation to which an evaluation fee is payable under subparagraph (aa)(iii) of item 4                                                                                                                                                                                                                                                                                                                                                                                                                                                                        | 39,068                                                                                                                                                                                                                                      |\n|              | (bca) for an application relating to a medicine in relation to which an evaluation fee is payable under paragraph (ab) of item 4                                                                                                                                                                                                                                                                                                                                                                                                                                                                               | 62,161                                                                                                                                                                                                                                      |\n|              | (bcb) for an application relating to a medicine in relation to which an evaluation fee is payable under paragraph (ac) of item 4                                                                                                                                                                                                                                                                                                                                                                                                                                                                               | 1,341                                                                                                                                                                                                                                       |\n|              | (bd) for an application relating to a medicine in relation to which an evaluation fee is payable under paragraph (b) of item 4                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 | 34,988                                                                                                                                                                                                                                      |\n|              | (be) for an application relating to a medicine in relation to which an evaluation fee is payable under subparagraph (bb)(i) or (ii) of item 4 for an evaluation of:                                                                                                                                                                                                                                                                                                                                                                                                                                            |                                                                                                                                                                                                                                             |\n|              | (i) an extension of indications                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                | 11,628                                                                                                                                                                                                                                      |\n|              | (ii) a major variation                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         | 7,591                                                                                                                                                                                                                                       |\n|              | (bf) for an application relating to a medicine in relation to which an evaluation fee is payable under subparagraph (bb)(iii) of item 4 for an evaluation of:                                                                                                                                                                                                                                                                                                                                                                                                                                                  |                                                                                                                                                                                                                                             |\n|              | (i) an extension of indications                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                | 23,442                                                                                                                                                                                                                                      |\n|              | (ii) a major variation                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         | 15,162                                                                                                                                                                                                                                      |\n|              | (bfa) for an application relating to a medicine in relation to which an evaluation fee is payable under paragraph (bd) of item 4                                                                                                                                                                                                                                                                                                                                                                                                                                                                               | 36,969                                                                                                                                                                                                                                      |\n|              | (bg) for an application relating to a medicine in relation to which an evaluation fee is payable under paragraph (c) of item 4                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 | 22,625                                                                                                                                                                                                                                      |\n|              | (bh) for an application relating to a medicine in relation to which an evaluation fee is payable under paragraph (d) of item 4                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 | 3,697                                                                                                                                                                                                                                       |\n|              | (bi) for an application relating to a medicine in relation to which an evaluation fee is payable under paragraph (g) of item 4                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 | 22,859                                                                                                                                                                                                                                      |\n|              | (bj) for an application relating to a medicine in relation to which an evaluation fee is payable under paragraph (h) of item 4                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 | 1,341                                                                                                                                                                                                                                       |\n|              | (bk) for an application relating to a medicine in relation to which an evaluation fee is payable under paragraph (bc) of item 4                                                                                                                                                                                                                                                                                                                                                                                                                                                                                | 1,341                                                                                                                                                                                                                                       |\n|              | (c) subject to paragraph (d), for an application in any other case                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             | 5,341                                                                                                                                                                                                                                       |\n|              | (d) if a person submits more than one application at the same time and:(i) the additional application is in relation to goods that contain the same therapeutically active ingredient; and(ii) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous evaluation of the goods to be made                                                                                                                                                                                                                                                       | 2,659—for each additional application, up to a maximum amount payable of 15,512 (including the fee payable under paragraph (c))                                                                                                             |\n| 2A           | Fee for varying an entry in the Register (not including evaluation of data) under section 9D (other than subsection 9D(2C)) of the Act, if the variation is for:                                                                                                                                                                                                                                                                                                                                                                                                                                               |                                                                                                                                                                                                                                             |\n|              | (a) a registered medicine that is mentioned in Part 1 of Schedule 10—for each submission                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       | 2,053                                                                                                                                                                                                                                       |\n|              | (b) a listed medicine                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          | 512                                                                                                                                                                                                                                         |\n|              | (c) a disinfectant                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             | 1,513                                                                                                                                                                                                                                       |\n|              | (d) a Class 3 or Class 4 IVD medical device that is not covered by paragraph (g)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               | 1,891                                                                                                                                                                                                                                       |\n|              | (e) an IVD medical device that is not:(i) a Class 3 or Class 4 IVD medical device; and(ii) covered by paragraph (g)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            | 1,081                                                                                                                                                                                                                                       |\n|              | (f) a medical device that is not:(i) an IVD medical device; and(ii) covered by paragraph (g)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   | 1,081                                                                                                                                                                                                                                       |\n|              | (g) a medical device, if the following are satisfied:(i) the reason for the variation is that the kind of medical device is affected by the EU transition (within the meaning of subregulation 9.1AA(3) of the Therapeutic Goods (Medical Devices) Regulations 2002);(ii) the variation only relates to an update to the manufacturer’s evidence for the medical device recorded in the entry in the Register for that kind of medical device;(iii) the request is to vary one or more entries in the Register and the manufacturer’s evidence to which the update relates is the same for each of the entries | 205 per 10 entries (or part thereof)                                                                                                                                                                                                        |\n| 2AC          | Application fee for an application under subsection 9D(3) of the Act to which regulation 16D applies                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           | 1,341                                                                                                                                                                                                                                       |\n| 2B           | Evaluation fee in relation to an application under subsection 9D(3) of the Act to which regulation 16F applies, for the evaluation of data—for each submission                                                                                                                                                                                                                                                                                                                                                                                                                                                 | 6,694                                                                                                                                                                                                                                       |\n| 2C           | Evaluation fee in relation to an application under subsection 9D(3) of the Act to which regulation 16D applies, for the evaluation of data—for each submission                                                                                                                                                                                                                                                                                                                                                                                                                                                 | 5,353                                                                                                                                                                                                                                       |\n| 2CA          | Evaluation fee in relation to an application under subsection 9D(2) of the Act, for the evaluation of data—for each submission                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 | 6,694                                                                                                                                                                                                                                       |\n| 2CB          | Fee for a request under subsection 9D(2C) of the Act (other than a request to which item 2CC, 2CD or 2CE applies) to make one or more variations of one or more entries in the Register in relation to a medicine:                                                                                                                                                                                                                                                                                                                                                                                             |                                                                                                                                                                                                                                             |\n|              | (a) for each entry, unless paragraph (b) applies                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               | 980                                                                                                                                                                                                                                         |\n|              | (b) in the case of a single entry in the Register, if the request is made together with a request of a kind mentioned in item 5 of Part 3 in relation to the same entry                                                                                                                                                                                                                                                                                                                                                                                                                                        | Nil                                                                                                                                                                                                                                         |\n| 2CC          | Fee for a request under subsection 9D(2C) of the Act to make the same variation or variations of 2 or more entries in the Register that each relate to a registered complementary medicine—for each group of up to 7 entries                                                                                                                                                                                                                                                                                                                                                                                   | 980                                                                                                                                                                                                                                         |\n| 2CD          | Fee for a request under subsection 9D(2C) of the Act to make the same variation or variations of 2 or more entries in the Register that each relate to a registered OTC medicine:                                                                                                                                                                                                                                                                                                                                                                                                                              |                                                                                                                                                                                                                                             |\n|              | (a) for each group of up to 7 entries, unless paragraph (b) applies                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            | 980                                                                                                                                                                                                                                         |\n|              | (b) for each group of up to 20 entries, if the request is made together with a request of a kind mentioned in item 5 of Part 3, in relation to the same group of entries                                                                                                                                                                                                                                                                                                                                                                                                                                       | Nil                                                                                                                                                                                                                                         |\n| 2CE          | Fee for a request under subsection 9D(2C) of the Act to make the same variation or variations of 2 or more entries in the Register if:(a) each entry relates to a prescription medicine or a biological medicine; and(b) 2 or more of those medicines have the same active ingredient                                                                                                                                                                                                                                                                                                                          | The sum of:(a) for each group of entries relating to medicines with the same active ingredient—980; and(b) for any other entry—980                                                                                                          |\n| 3            | Application fee for paragraph 23C(2)(c) of the Act for the listing of therapeutic goods (other than for an application to which regulation 43A applies) if the goods are:                                                                                                                                                                                                                                                                                                                                                                                                                                      |                                                                                                                                                                                                                                             |\n|              | (a) a disinfectant                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             | 2,377                                                                                                                                                                                                                                       |\n|              | (b) a medicine                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 | 1,014                                                                                                                                                                                                                                       |\n| 3AB          | Fee for a notice and declaration under subregulation 43AAE(2) relating to an exemption from liability to pay an annual registration charge, annual listing charge or annual charge for inclusion in the Register in respect of therapeutic goods for a financial year:                                                                                                                                                                                                                                                                                                                                         |                                                                                                                                                                                                                                             |\n|              | (a) if the notice and declaration relate to not more than 5 entries in the Register                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            | 512                                                                                                                                                                                                                                         |\n|              | (b) if the notice and declaration relate to 6 or more entries in the Register                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  | 512 for the first 5 entries plus 59 for each additional entry                                                                                                                                                                               |\n| 4            | Evaluation fee, for subsection 24(1A) of the Act, under a submission for evaluation relating to:                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               |                                                                                                                                                                                                                                             |\n|              | (a) a new chemical entity (other than an entity to which paragraph (aa), (ab) or (ac) of this item, paragraph (a) of item 1AD or item 1AF applies)                                                                                                                                                                                                                                                                                                                                                                                                                                                             | 235,115                                                                                                                                                                                                                                     |\n|              | (aa) a new chemical entity incorporated as an ancillary medicinal component of a medical device if the evaluation of the new chemical entity involves an evaluation of:                                                                                                                                                                                                                                                                                                                                                                                                                                        |                                                                                                                                                                                                                                             |\n|              | (i) documentation setting out the chemistry, quality control and manufacturing of the new chemical entity; or                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  | 78,489                                                                                                                                                                                                                                      |\n|              | (ii) documentation relating to pre‑clinical studies; or                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        | 78,489                                                                                                                                                                                                                                      |\n|              | (iii) documentation mentioned in subparagraphs (i) and (ii)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    | 156,394                                                                                                                                                                                                                                     |\n|              | (ab) a new prescription medicine in relation to which a therapeutic goods (priority applicant) determination is in force                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       | 248,644                                                                                                                                                                                                                                     |\n|              | (ac) a vaccine for COVID‑19, respiratory syncytial virus (RSV) or influenza that is a new chemical entity, if:(i) the vaccine is a new chemical entity only because the vaccine is for a new strain; and(ii) the vaccine is a closely related form of an existing vaccine, for another strain, in the Register in relation to which the applicant is the sponsor                                                                                                                                                                                                                                               | 5,353                                                                                                                                                                                                                                       |\n|              | (b) an extension of indications (other than an extension of indications to which paragraph (bb), (bc) or (bd) of this item, paragraph (b) of item 1AD or item 1AF applies)                                                                                                                                                                                                                                                                                                                                                                                                                                     | 139,483                                                                                                                                                                                                                                     |\n|              | (bb) an extension of indications or a major variation in respect of a medicine incorporated as an ancillary medicinal component of a medical device if the evaluation of the medicine involves an evaluation of:                                                                                                                                                                                                                                                                                                                                                                                               |                                                                                                                                                                                                                                             |\n|              | (i) documentation setting out the chemistry, quality control and manufacturing of the medicine; or                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             | for an evaluation relating to:(a) an extension of indications—46,533(b) a major variation—30,206                                                                                                                                            |\n|              | (ii) documentation relating to pre‑clinical studies; or                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        | for an evaluation relating to:(a) an extension of indications—46,533(b) a major variation—30,206                                                                                                                                            |\n|              | (iii) documentation mentioned in subparagraphs (i) and (ii)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    | for an evaluation relating to:(a) an extension of indications—92,949(b) a major variation—60,762                                                                                                                                            |\n|              | (bc) an extension of indications that is the subject of an application to which regulation 16G applies                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         | 5,353                                                                                                                                                                                                                                       |\n|              | (bd) a new indications medicine in relation to which a therapeutic goods (priority applicant) determination is in force                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        | 147,880                                                                                                                                                                                                                                     |\n|              | (c) a new generic product                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      | 89,801                                                                                                                                                                                                                                      |\n|              | (d) an additional trade name                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   | 14,695                                                                                                                                                                                                                                      |\n|              | (g) a major variation (that is not a variation mentioned in any of paragraphs (a) to (d))                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      | 90,967                                                                                                                                                                                                                                      |\n|              | (h) a minor variation (that is not a variation mentioned in any of paragraphs (a) to (d))                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      | 5,353                                                                                                                                                                                                                                       |\n| 6AA          | Fee for processing of data in relation to goods, a step in the manufacture of which was carried out outside Australia (in addition to any other fee prescribed in this Schedule in relation to the application) to determine whether the manufacturing and quality control procedures used in the manufacture of the goods are acceptable:(a) for the purposes of subsection 9D(1), (2) or (3) of the Act; or(b) for the purposes of paragraph 25(1)(g), 26(1)(g), 31(1)(e) or 31(2)(d) of the Act                                                                                                             | 781                                                                                                                                                                                                                                         |\n| 6AB          | Fee for Department obtaining evidence from overseas regulatory authority of the manufacturing and quality control procedures used in the manufacture of goods, a step in the manufacture of which was carried out outside Australia (in addition to fee prescribed in item 6AA)                                                                                                                                                                                                                                                                                                                                | 840                                                                                                                                                                                                                                         |\n| 6ABA         | Fee for desk audit of overseas compliance certification to identify third party certifications and review the overseas compliance certification by examining the underlying audit report and obtaining information from the overseas regulators                                                                                                                                                                                                                                                                                                                                                                | 2,987                                                                                                                                                                                                                                       |\n| 6AC          | Fee for reinstatement of acceptance status of data relating to the manufacturing and quality control procedures used in the manufacture of goods, a step in the manufacture of which was carried out outside Australia (in addition to fee prescribed in items 6AA and 6ABA)                                                                                                                                                                                                                                                                                                                                   | 1,411                                                                                                                                                                                                                                       |\n| 6B           | Fee for evaluation of data, under subsection 9D(1), (2) or (3) of the Act, about an entry in the Register relating to disinfectants                                                                                                                                                                                                                                                                                                                                                                                                                                                                            | 4,489                                                                                                                                                                                                                                       |\n| 6BA          | Application fee for a request, under subsection 30A(1) of the Act, for the revocation of the cancellation of the registration or listing of therapeutic goods from the Register:                                                                                                                                                                                                                                                                                                                                                                                                                               |                                                                                                                                                                                                                                             |\n|              | (a) if the request relates to one registration or listing;                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     | 187                                                                                                                                                                                                                                         |\n|              | (b) if the request relates to more than one registration or listing                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            | 187 for the first registration or listing plus 59 for each additional registration or listing                                                                                                                                               |\n| 6BB          | Application fee for a request, under subsection 30AA(1) of the Act, for the revocation of the cancellation of the registration or listing of therapeutic goods:                                                                                                                                                                                                                                                                                                                                                                                                                                                |                                                                                                                                                                                                                                             |\n|              | (a) if the request relates to one registration or listing;                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     | 187                                                                                                                                                                                                                                         |\n|              | (b) if the request relates to more than one registration or listing                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            | 187 for the first registration or listing plus 59 for each additional registration or listing                                                                                                                                               |\n| 6C           | Fee for evaluating documents and other information, relating to the safety of a medicine, obtained under paragraph 31(2)(f) of the Act (other than an evaluation to which item 6D applies)                                                                                                                                                                                                                                                                                                                                                                                                                     | 9,749                                                                                                                                                                                                                                       |\n| 6D           | Fee for evaluating documents and other information, relating to the safety, quality and efficacy of a medicine, obtained under paragraphs 31(2)(f) and (h) of the Act, if the total number of pages of the evaluation documentation is:                                                                                                                                                                                                                                                                                                                                                                        |                                                                                                                                                                                                                                             |\n|              | (a) not over 50 pages                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          | 12,829                                                                                                                                                                                                                                      |\n|              | (b) over 50 pages, but not over 250 pages                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      | 16,561                                                                                                                                                                                                                                      |\n|              | (c) over 250 pages, but not over 500 pages                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     | 22,625                                                                                                                                                                                                                                      |\n|              | (d) over 500 pages, but not over 1 000 pages                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   | 29,972                                                                                                                                                                                                                                      |\n|              | (e) over 1 000 pages, but not over 2 000 pages                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 | 44,900                                                                                                                                                                                                                                      |\n|              | (f) over 2 000 pages, but not over 3 000 pages                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 | 59,828                                                                                                                                                                                                                                      |\n|              | (g) over 3 000 pages                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           | 89,801                                                                                                                                                                                                                                      |\n| 7A           | Fee for evaluation under paragraph 16GA(1)(a):                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 |                                                                                                                                                                                                                                             |\n|              | (a) if the evaluation documentation does not contain clinical or toxicological information(b) if the evaluation documentation contains clinical or toxicological information, and the total number of pages is:                                                                                                                                                                                                                                                                                                                                                                                                | 12,829                                                                                                                                                                                                                                      |\n|              | (i) not over 50 pages                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          | 12,829                                                                                                                                                                                                                                      |\n|              | (ii) over 50 pages, but not over 250 pages                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     | 16,561                                                                                                                                                                                                                                      |\n|              | (iii) over 250 pages, but not over 500 pages                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   | 22,625                                                                                                                                                                                                                                      |\n|              | (iv) over 500 pages, but not over 1 000 pages                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  | 29,972                                                                                                                                                                                                                                      |\n|              | (v) over 1 000 pages, but not over 2 000 pages                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 | 44,900                                                                                                                                                                                                                                      |\n|              | (vi) over 2 000 pages, but not over 3 000 pages                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                | 59,828                                                                                                                                                                                                                                      |\n|              | (vii) over 3 000 pages                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         | 89,801                                                                                                                                                                                                                                      |\n| 7B           | Fee for evaluation, under paragraph 16GA(1)(b), in relation to 1 or more new excipients for use in particular therapeutic goods:                                                                                                                                                                                                                                                                                                                                                                                                                                                                               |                                                                                                                                                                                                                                             |\n|              | (a) if the evaluation documentation does not contain clinical or toxicological information(b) if the evaluation documentation contains clinical or toxicological information, and the total number of pages is:                                                                                                                                                                                                                                                                                                                                                                                                | 12,829                                                                                                                                                                                                                                      |\n|              | (i) not over 50 pages                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          | 12,829                                                                                                                                                                                                                                      |\n|              | (ii) over 50 pages, but not over 250 pages                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     | 16,561                                                                                                                                                                                                                                      |\n|              | (iii) over 250 pages, but not over 500 pages                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   | 22,625                                                                                                                                                                                                                                      |\n|              | (iv) over 500 pages, but not over 1 000 pages                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  | 29,972                                                                                                                                                                                                                                      |\n|              | (v) over 1 000 pages, but not over 2 000 pages                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 | 44,900                                                                                                                                                                                                                                      |\n|              | (vi) over 2 000 pages, but not over 3 000 pages                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                | 59,828                                                                                                                                                                                                                                      |\n|              | (vii) over 3 000 pages                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         | 89,801                                                                                                                                                                                                                                      |\n| 7C           | Application fee for the purposes of paragraph 26BJ(2)(d) of the Act                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            | 1,270                                                                                                                                                                                                                                       |\n| 8            | (a) Application fee for the purposes of paragraph 37(1)(g) of the Act, for a licence for:                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      | 957                                                                                                                                                                                                                                         |\n|              | (i) the manufacture of therapeutic goods; or                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   |                                                                                                                                                                                                                                             |\n|              | (ii) one or more steps in the manufacture of therapeutic goods; or                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             |                                                                                                                                                                                                                                             |\n|              | (iii) the manufacture of ingredients or components for use in the manufacture of therapeutic goods; or                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         |                                                                                                                                                                                                                                             |\n|              | (iv) the manufacture of herbal or homoeopathic preparations;                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   |                                                                                                                                                                                                                                             |\n|              | unless paragraph (b) applies                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   |                                                                                                                                                                                                                                             |\n|              | (b) Application fee for the purposes of paragraph 37(1)(g) of the Act, for a licence for:                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      | 1,248                                                                                                                                                                                                                                       |\n|              | (i) the manufacture of haematopoietic progenitor cells; or                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     |                                                                                                                                                                                                                                             |\n|              | (ii) the manufacture of human blood and blood components (other than haematopoietic progenitor cells)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          |                                                                                                                                                                                                                                             |\n| 8A           | Application fee for the purposes of paragraph 40B(2)(g) of the Act, for an application under subsection 40B(1) of the Act (addition of manufacturing sites) for the variation of a licence to which paragraph (a) of item 8 applies                                                                                                                                                                                                                                                                                                                                                                            | 957                                                                                                                                                                                                                                         |\n| 8B           | Application fee for the purposes of paragraph 40B(7)(d) of the Act, for an application under subsection 40B(6) of the Act for the variation of the manufacturing site authorisation in relation to a licence to which paragraph (a) of item 8 applies                                                                                                                                                                                                                                                                                                                                                          | 957                                                                                                                                                                                                                                         |\n| 8C           | Application fee for the purposes of paragraph 40B(9B)(c) of the Act, for an application under subsection 40B(9A) of the Act (removal of manufacturing sites) for the variation of a licence to which paragraph (a) of item 8 applies                                                                                                                                                                                                                                                                                                                                                                           | 957                                                                                                                                                                                                                                         |\n| 9            | (a) Fee for paragraphs 38(1)(c) and 58(3)(b) of the Act for inspection within Australia (except for therapeutic goods mentioned in items 9AA, 9AB, 9AC and 9ACA), per hour, per inspector, for:                                                                                                                                                                                                                                                                                                                                                                                                                | 1,190                                                                                                                                                                                                                                       |\n|              | (i) the manufacture of therapeutic goods; or                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   |                                                                                                                                                                                                                                             |\n|              | (ii) one or more steps in the manufacture of therapeutic goods; or                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             |                                                                                                                                                                                                                                             |\n|              | (iii) the manufacture of ingredients or components for use in the manufacture of therapeutic goods; or                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         |                                                                                                                                                                                                                                             |\n|              | (iv) the manufacture of herbal or homoeopathic preparations                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    |                                                                                                                                                                                                                                             |\n|              | (b) Fee for inspection outside Australia, per hour, per inspector, for inspection of a kind mentioned in paragraph (a)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         | 1,668                                                                                                                                                                                                                                       |\n| 9AA          | Fee for inspection (including an inspection for paragraph 58(3)(b) of the Act) of manufacturing premises or operations for the preparation of haematopoietic progenitor cells under licence, for each inspector engaged per hour, or part of an hour                                                                                                                                                                                                                                                                                                                                                           | 815                                                                                                                                                                                                                                         |\n| 9AB          | Fee for inspection (including an inspection for paragraph 58(3)(b) of the Act) of manufacturing premises or operations for the preparation of human blood and blood components (other than haematopoietic progenitor cells) under licence, at the primary site covered by the licence, for each inspector engaged per hour, or part of an hour                                                                                                                                                                                                                                                                 | 1,108                                                                                                                                                                                                                                       |\n| 9AC          | Fee for inspection (including an inspection for paragraph 58(3)(b) of the Act) of manufacturing premises or operations for the preparation of human blood and blood components (other than haematopoietic progenitor cells) under licence, at a site covered by the licence (other than a site to which item 9AB applies), for each inspector engaged per hour, or part of an hour                                                                                                                                                                                                                             | 815                                                                                                                                                                                                                                         |\n| 9ACA         | Fee for inspection (including an inspection for paragraph 58(3)(b) of the Act) of manufacturing premises or operations for the preparation of human tissues under licence, for each inspector engaged per hour, or part of an hour                                                                                                                                                                                                                                                                                                                                                                             | 815                                                                                                                                                                                                                                         |\n| 9AD          | Fee for paragraph 25(1)(g) or (h), or 26(1)(g) or (h) of the Act (and, in relation to associated inspections, for paragraphs 38(1)(c), 41(1)(f) and 58(3)(b) of the Act), in respect of the evaluation of the manufacture of human blood and blood components prepared under licence by reference to data contained in files known as technical master files or plasma master files, where the total number of pages of each file referred to is:                                                                                                                                                              |                                                                                                                                                                                                                                             |\n|              | (a) not over 10 pages                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          | 1,610                                                                                                                                                                                                                                       |\n|              | (b) over 10 pages, but not over 50 pages                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       | 13,645                                                                                                                                                                                                                                      |\n|              | (c) over 50 pages, but not over 100 pages                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      | 30,788                                                                                                                                                                                                                                      |\n|              | (d) over 100 pages, but not over 1 000 pages                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   | 41,402                                                                                                                                                                                                                                      |\n|              | (e) over 1 000 pages, but not over 3 000 pages                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 | 64,493                                                                                                                                                                                                                                      |\n|              | (f) over 3 000 pages, but not over 4 000 pages                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 | 85,952                                                                                                                                                                                                                                      |\n|              | (g) over 4 000 pages                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           | 104,845                                                                                                                                                                                                                                     |\n| 9D           | Fee for evaluation, under subsection 9D(1), (2) or (3), subsection 24(1A) or paragraph 26(1)(d) of the Act, of data relating to the device component, to which Chapter 4 of the Act applies, of a medicine (in addition to the fee prescribed in item 4, or in Part 3 of this Schedule, for evaluating the medicine)                                                                                                                                                                                                                                                                                           | The fee applicable, under item 1.9, 1.10, 1.12 or 1.16 (and, if applicable, clause 2.2) of Schedule 5 to the Therapeutic Goods (Medical Devices) Regulations 2002, to the kind of work to be undertaken                                     |\n| 10           | Fee for an application for certification under paragraph 58(3)(a) of the Act                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   | 211 multiplied by the number of certifications sought in the application                                                                                                                                                                    |\n| 11           | Fee for the inspection of manufacturing operations other than for the purposes of Part 3‑3 of the Act                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          | The fee applicable under item 9 for that step of manufacture                                                                                                                                                                                |\n| 12           | Fee for evaluation of data in relation to therapeutic goods specified in Schedule 10 for the purposes of subsection 9D(1), (2) or (3) of the Act that is not covered by another item in this Part                                                                                                                                                                                                                                                                                                                                                                                                              | The fee applicable under item 1, 4 or 5 for an evaluation of that nature                                                                                                                                                                    |\n| 13           | Fee for an evaluation under subsection 66(4) of the Act                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        | The fee applicable under item 1, 4 or 5 for an evaluation of that nature                                                                                                                                                                    |\n| 14           | Fee for notification required under item 3 of Schedule 5A:                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     |                                                                                                                                                                                                                                             |\n|              | (a) of intention to sponsor a clinical trial at a trial site using a specified medicine                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        | 443                                                                                                                                                                                                                                         |\n|              | (b) for each notification of an additional trial site or additional trial sites                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                | 443                                                                                                                                                                                                                                         |\n| 16           | Fee, including deposit, for an application under subsection 61(6) of the Act                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   | The amount, including a deposit, that would be payable under the Freedom of Information Act 1982 and the Freedom of Information (Fees and Charges) Regulations for a request if the application were a request under section 15 of that Act |\n| 18           | Fee for providing advice in relation to a prescription medicine at the request of the sponsor of the medicine for the purpose of listing the medicine as a pharmaceutical benefit                                                                                                                                                                                                                                                                                                                                                                                                                              | 2,706                                                                                                                                                                                                                                       |\n\n## Part 3 Table of fees for applications etc. in relation to certain OTC medicines\n\n## Part 3—Table of fees for applications etc. in relation to certain OTC medicines\n\n## 4 Table of fees\n\n#### 4 Table of fees\n\n  The following table sets out particular fees for applications, evaluations and requests in relation to OTC medicines that are, or are to be, registered goods.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"TableHeading\"><span>Fees</span></p></td><td style=\"border-bottom:0.75pt solid #000000; vertical-align:top\"></td></tr><tr><td style=\"width:13.34%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span><br><span>Item</span></p></td><td style=\"width:62.12%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span><br><span>Matter</span></p></td><td colspan=\"2\" style=\"border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span><br><span>Fee $</span></p></td></tr></thead><tbody><tr><td style=\"width:13.34%; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:62.12%; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Application fee under paragraph</span><span> </span><span>23B(2)(b) of the Act:</span></p></td><td colspan=\"2\" style=\"border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span></span></p></td></tr><tr><td style=\"width:13.34%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span></span></p></td><td style=\"width:62.12%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) for an N1 application</span></p></td><td colspan=\"2\" style=\"padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1,982</span></p></td></tr><tr><td style=\"width:13.34%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span></span></p></td><td style=\"width:62.12%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(b) for an N2 application</span></p></td><td colspan=\"2\" style=\"padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1,982</span></p></td></tr><tr><td style=\"width:13.34%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span></span></p></td><td style=\"width:62.12%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(c) for an N3 application</span></p></td><td colspan=\"2\" style=\"padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3,185</span></p></td></tr><tr><td style=\"width:13.34%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span></span></p></td><td style=\"width:62.12%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(d) for an N4 application</span></p></td><td colspan=\"2\" style=\"padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4,653</span></p></td></tr><tr><td style=\"width:13.34%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span></span></p></td><td style=\"width:62.12%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(e) for an N5 application</span></p></td><td colspan=\"2\" style=\"padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6,893</span></p></td></tr><tr><td style=\"width:13.34%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span></span></p></td><td style=\"width:62.12%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(f) for a C1 (section</span><span> </span><span>23) application</span></p></td><td colspan=\"2\" style=\"padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1,982</span></p></td></tr><tr><td style=\"width:13.34%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span></span></p></td><td style=\"width:62.12%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(g) for a C2 (section</span><span> </span><span>23) application</span></p></td><td colspan=\"2\" style=\"padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1,982</span></p></td></tr><tr><td style=\"width:13.34%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span></span></p></td><td style=\"width:62.12%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(h) for a C3 (section</span><span> </span><span>23) application</span></p></td><td colspan=\"2\" style=\"padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1,982</span></p></td></tr><tr><td style=\"width:13.34%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span></span></p></td><td style=\"width:62.12%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(i) for a C4 (section</span><span> </span><span>23) application</span></p></td><td colspan=\"2\" style=\"border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3,185</span></p></td></tr><tr><td style=\"width:13.34%; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:62.12%; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Evaluation fee under subsection</span><span> </span><span>24(1A) of the Act:</span></p></td><td colspan=\"2\" style=\"border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span></span></p></td></tr><tr><td style=\"width:13.34%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span></span></p></td><td style=\"width:62.12%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) for an N1 application</span></p></td><td colspan=\"2\" style=\"padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4,898</span></p></td></tr><tr><td style=\"width:13.34%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span></span></p></td><td style=\"width:62.12%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(b) for an N2 application</span></p></td><td colspan=\"2\" style=\"padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6,963</span></p></td></tr><tr><td style=\"width:13.34%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span></span></p></td><td style=\"width:62.12%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(c) for an N3 application</span></p></td><td colspan=\"2\" style=\"padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10,730</span></p></td></tr><tr><td style=\"width:13.34%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span></span></p></td><td style=\"width:62.12%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(d) for an N4 application</span></p></td><td colspan=\"2\" style=\"padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17,843</span></p></td></tr><tr><td style=\"width:13.34%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span></span></p></td><td style=\"width:62.12%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(e) for an N5 application</span></p></td><td colspan=\"2\" style=\"padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26,240</span></p></td></tr><tr><td style=\"width:13.34%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span></span></p></td><td style=\"width:62.12%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(f) for a C2 (section</span><span> </span><span>23) application</span></p></td><td colspan=\"2\" style=\"padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4,898</span></p></td></tr><tr><td style=\"width:13.34%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span></span></p></td><td style=\"width:62.12%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(g) for a C3 (section</span><span> </span><span>23) application</span></p></td><td colspan=\"2\" style=\"padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8,222</span></p></td></tr><tr><td style=\"width:13.34%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span></span></p></td><td style=\"width:62.12%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(h) for a C4 (section</span><span> </span><span>23) application</span></p></td><td colspan=\"2\" style=\"border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10,730</span></p></td></tr><tr><td style=\"width:13.34%; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:62.12%; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If, at the time a person submits an application of a kind mentioned in paragraph</span><span> </span><span>(a), (b), (c), (d) or (e) of item</span><span> </span><span>1:</span></p></td><td colspan=\"2\" style=\"border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span></span></p></td></tr><tr><td style=\"width:13.34%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span></span></p></td><td style=\"width:62.12%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) the person also submits an additional application or applications of the same kind; and</span></p></td><td colspan=\"2\" style=\"padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span></span></p></td></tr><tr><td style=\"width:13.34%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span></span></p></td><td style=\"width:62.12%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(b) each application relates to goods that contain the same therapeutically active ingredient; and</span></p></td><td colspan=\"2\" style=\"padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span></span></p></td></tr><tr><td style=\"width:13.34%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span></span></p></td><td style=\"width:62.12%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(c) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous assessment of the goods to be made;</span></p></td><td colspan=\"2\" style=\"padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span></span></p></td></tr><tr><td style=\"width:13.34%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span></span></p></td><td style=\"width:62.12%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the application fee under paragraph</span><span> </span><span>23B(2)(b) of the Act for each additional application is:</span></p></td><td colspan=\"2\" style=\"padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span></span></p></td></tr><tr><td style=\"width:13.34%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span></span></p></td><td style=\"width:62.12%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(d) for an additional N1 application</span></p></td><td colspan=\"2\" style=\"padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1,003</span></p></td></tr><tr><td style=\"width:13.34%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span></span></p></td><td style=\"width:62.12%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(e) for an additional N2 application</span></p></td><td colspan=\"2\" style=\"padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1,003</span></p></td></tr><tr><td style=\"width:13.34%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span></span></p></td><td style=\"width:62.12%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(f) for an additional N3 application</span></p></td><td colspan=\"2\" style=\"padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1,599</span></p></td></tr><tr><td style=\"width:13.34%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span></span></p></td><td style=\"width:62.12%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(g) for an additional N4 application</span></p></td><td colspan=\"2\" style=\"padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1,599</span></p></td></tr><tr><td style=\"width:13.34%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span></span></p></td><td style=\"width:62.12%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(h) for an additional N5 application</span></p></td><td colspan=\"2\" style=\"border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1,599</span></p></td></tr><tr><td style=\"width:13.34%; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:62.12%; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>If, at the time a person submits an application of a kind mentioned in paragraph</span><span> </span><span>(c), (d) or (e) of item</span><span> </span><span>2:</span></p></td><td colspan=\"2\" style=\"border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span></span></p></td></tr><tr><td style=\"width:13.34%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span></span></p></td><td style=\"width:62.12%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) the person also submits an additional application or applications of the same kind; and</span></p></td><td colspan=\"2\" style=\"padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span></span></p></td></tr><tr><td style=\"width:13.34%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span></span></p></td><td style=\"width:62.12%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(b) each application relates to goods that contain the same therapeutically active ingredient; and</span></p></td><td colspan=\"2\" style=\"padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span></span></p></td></tr><tr><td style=\"width:13.34%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span></span></p></td><td style=\"width:62.12%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(c) the information in support of each application is sufficiently common in respect of the goods to enable a simultaneous evaluation of the goods to be made;</span></p></td><td colspan=\"2\" style=\"padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span></span></p></td></tr><tr><td style=\"width:13.34%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span></span></p></td><td style=\"width:62.12%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>the evaluation fee under subsection</span><span> </span><span>24(1A) of the Act for each additional application is:</span></p></td><td colspan=\"2\" style=\"padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span></span></p></td></tr><tr><td style=\"width:13.34%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span></span></p></td><td style=\"width:62.12%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(d) for an additional N3 application</span></p></td><td colspan=\"2\" style=\"padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5,435</span></p></td></tr><tr><td style=\"width:13.34%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span></span></p></td><td style=\"width:62.12%; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(e) for an additional N4 application</span></p></td><td colspan=\"2\" style=\"padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5,435</span></p></td></tr><tr><td style=\"width:13.34%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span></span></p></td><td style=\"width:62.12%; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(f) for an additional N5 application</span></p></td><td colspan=\"2\" style=\"border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5,435</span></p></td></tr><tr><td style=\"width:13.34%; border-top:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:62.12%; border-top:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>Application fee under paragraph</span><span> </span><span>9D(7)(f) of the Act, for any of the following requests in relation to up to 20 entries in the Register:</span></p></td><td colspan=\"2\" style=\"border-top:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span></span></p></td></tr><tr><td style=\"width:13.34%; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span></span></p></td><td style=\"width:62.12%; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) a C1 (section</span><span> </span><span>9D) application</span></p></td><td colspan=\"2\" style=\"padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>1,982</span></p></td></tr><tr><td style=\"width:13.34%; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span></span></p></td><td style=\"width:62.12%; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tablea\"><span>(b) a C2 (section</span><span> </span><span>9D) application</span></p></td><td colspan=\"2\" style=\"padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>6,893</span></p></td></tr><tr><td style=\"width:13.34%; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span></span></p></td><td style=\"width:62.12%; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tablea\"><span>(c) a C3 (section</span><span> </span><span>9D) application</span></p></td><td colspan=\"2\" style=\"padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>10,216</span></p></td></tr><tr><td style=\"width:13.34%; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span></span></p></td><td style=\"width:62.12%; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tablea\"><span>(d) a C4 (section</span><span> </span><span>9D) application</span></p></td><td colspan=\"2\" style=\"border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>13,878</span></p></td></tr><tr><td style=\"width:13.34%; border-top:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:62.12%; border-top:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>Fee for providing advice in relation to a registered OTC medicine at the request of the sponsor of the medicine for the purpose of listing the medicine as a pharmaceutical benefit:</span></p></td><td colspan=\"2\" style=\"border-top:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span></span></p></td></tr><tr><td style=\"width:13.34%; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span></span></p></td><td style=\"width:62.12%; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tablea\"><span>(a) if the request does not contain clinical data</span></p></td><td colspan=\"2\" style=\"padding-right:5.35pt; padding-left:5.35pt; vertical-align:top\"><p class=\"Tabletext\"><span>1,947</span></p></td></tr><tr><td style=\"width:13.34%; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span></span></p></td><td style=\"width:62.12%; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tablea\"><span>(b) if the request contains clinical data or a justification as to why such data is not needed</span></p></td><td colspan=\"2\" style=\"border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9,984</span></p></td></tr><tr style=\"height:0pt\"><td style=\"width:56.9pt\"></td><td style=\"width:264.85pt\"></td><td style=\"width:103.6pt\"></td><td style=\"width:1pt\"></td></tr></tbody></table>\n```\n\n## Part 4 Table of fees for applications etc. in relation to certain complementary medicines and certain other listed medicines\n\n## Part 4—Table of fees for applications etc. in relation to certain complementary medicines and certain other listed medicines\n\n## 5 Table of fees\n\n#### 5 Table of fees\n\n  The following table sets out particular fees for applications, evaluations and requests in relation to certain medicines.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:100%; border-collapse:collapse\"><thead><tr><td colspan=\"3\" style=\"border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Fees</span></p></td></tr><tr><td style=\"width:7.56%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:79.48%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span></p><p class=\"TableHeading\"><span>Matter</span></p></td><td style=\"width:12.96%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\" style=\"text-align:right\"><span>Column 2</span></p><p class=\"TableHeading\" style=\"text-align:right\"><span>Fee $</span></p></td></tr></thead><tbody><tr><td style=\"width:7.56%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1A</span></p></td><td style=\"width:79.48%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Application fee under paragraph</span><span> </span><span>9D(7)(f) of the Act for an L(A)C1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:12.96%; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"text-align:right\"><span>2,390</span></p></td></tr><tr><td style=\"width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1B</span></p></td><td style=\"width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Application fee under paragraph</span><span> </span><span>9D(7)(f) of the Act for an L(A)C2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"text-align:right\"><span>10,439</span></p></td></tr><tr><td style=\"width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1C</span></p></td><td style=\"width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Application fee under paragraph</span><span> </span><span>9D(7)(f) of the Act for an L(A)CN (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"text-align:right\"><span>957</span></p></td></tr><tr><td style=\"width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1D</span></p></td><td style=\"width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Application fee under paragraph</span><span> </span><span>23B(2)(b) of the Act for an L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"text-align:right\"><span>1,108</span></p></td></tr><tr><td style=\"width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1E</span></p></td><td style=\"width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Application fee under paragraph</span><span> </span><span>23B(2)(b) of the Act for an L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"text-align:right\"><span>1,108</span></p></td></tr><tr><td style=\"width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1F</span></p></td><td style=\"width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Application fee under paragraph</span><span> </span><span>23B(2)(b) of the Act for an L(A)CN (section</span><span> </span><span>23) application</span></p></td><td style=\"width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"text-align:right\"><span>957</span></p></td></tr><tr><td style=\"width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1G</span></p></td><td style=\"width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Evaluation fee under subsection</span><span> </span><span>26AC(2) of the Act for an L(A)C1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"text-align:right\"><span>1,284</span></p></td></tr><tr><td style=\"width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1H</span></p></td><td style=\"width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Evaluation fee under subsection</span><span> </span><span>26AC(2) of the Act for an L(A)C2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"text-align:right\"><span>9,330</span></p></td></tr><tr><td style=\"width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Application fee under paragraph</span><span> </span><span>9D(7)(f) of the Act for an RCMC1 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"text-align:right\"><span>1,739</span></p></td></tr><tr><td style=\"width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Application fee under paragraph</span><span> </span><span>9D(7)(f) of the Act for an RCMC2 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"text-align:right\"><span>5,866</span></p></td></tr><tr><td style=\"width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Application fee under paragraph</span><span> </span><span>9D(7)(f) of the Act for an RCMC3 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"text-align:right\"><span>8,712</span></p></td></tr><tr><td style=\"width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Application fee under paragraph</span><span> </span><span>9D(7)(f) of the Act for an RCMC4 (section</span><span> </span><span>9D) request</span></p></td><td style=\"width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"text-align:right\"><span>12,363</span></p></td></tr><tr><td style=\"width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Application fee under paragraph</span><span> </span><span>23B(2)(b) of the Act for an RCMC1 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"text-align:right\"><span>1,739</span></p></td></tr><tr><td style=\"width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Application fee under paragraph</span><span> </span><span>23B(2)(b) of the Act for an RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"text-align:right\"><span>910</span></p></td></tr><tr><td style=\"width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Evaluation fee under subsection</span><span> </span><span>24(1A) of the Act for an RCMC2 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"text-align:right\"><span>4,944</span></p></td></tr><tr><td style=\"width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Application fee under paragraph</span><span> </span><span>23B(2)(b) of the Act for an RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"text-align:right\"><span>980</span></p></td></tr><tr><td style=\"width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>9</span></p></td><td style=\"width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Evaluation fee under subsection</span><span> </span><span>24(1A) of the Act for an RCMC3 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"text-align:right\"><span>7,744</span></p></td></tr><tr><td style=\"width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Application fee under paragraph</span><span> </span><span>23B(2)(b) of the Act for an RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"text-align:right\"><span>1,003</span></p></td></tr><tr><td style=\"width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>11</span></p></td><td style=\"width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Evaluation fee under subsection</span><span> </span><span>24(1A) of the Act for an RCMC4 (section</span><span> </span><span>23) application</span></p></td><td style=\"width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"text-align:right\"><span>11,441</span></p></td></tr><tr><td style=\"width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>12</span></p></td><td style=\"width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Application fee under paragraph</span><span> </span><span>23B(2)(b) of the Act for an RCM1 application</span></p></td><td style=\"width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"text-align:right\"><span>665</span></p></td></tr><tr><td style=\"width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>13</span></p></td><td style=\"width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Evaluation fee under subsection</span><span> </span><span>24(1A) of the Act for a RCM1 application</span></p></td><td style=\"width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"text-align:right\"><span>3,813</span></p></td></tr><tr><td style=\"width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>14</span></p></td><td style=\"width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Application fee under paragraph</span><span> </span><span>23B(2)(b) of the Act for an RCM2 application</span></p></td><td style=\"width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"text-align:right\"><span>2,390</span></p></td></tr><tr><td style=\"width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>15</span></p></td><td style=\"width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Evaluation fee under subsection</span><span> </span><span>24(1A) of the Act for a RCM2 application</span></p></td><td style=\"width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"text-align:right\"><span>25,540</span></p></td></tr><tr><td style=\"width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>16</span></p></td><td style=\"width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Application fee under paragraph</span><span> </span><span>23B(2)(b) of the Act for an RCM3 application</span></p></td><td style=\"width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"text-align:right\"><span>2,390</span></p></td></tr><tr><td style=\"width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>17</span></p></td><td style=\"width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Evaluation fee under subsection</span><span> </span><span>24(1A) of the Act for a RCM3 application</span></p></td><td style=\"width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"text-align:right\"><span>25,540</span></p></td></tr><tr><td style=\"width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>18</span></p></td><td style=\"width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Application fee under paragraph</span><span> </span><span>23B(2)(b) of the Act for an RCM4 application</span></p></td><td style=\"width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"text-align:right\"><span>3,160</span></p></td></tr><tr><td style=\"width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>19</span></p></td><td style=\"width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Evaluation fee under subsection</span><span> </span><span>24(1A) of the Act for a RCM4 application</span></p></td><td style=\"width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"text-align:right\"><span>34,755</span></p></td></tr><tr><td style=\"width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>20</span></p></td><td style=\"width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Application fee under paragraph</span><span> </span><span>23B(2)(b) of the Act for an RCM5 application</span></p></td><td style=\"width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"text-align:right\"><span>3,463</span></p></td></tr><tr><td style=\"width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>21</span></p></td><td style=\"width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Evaluation fee under subsection</span><span> </span><span>24(1A) of the Act for a RCM5 application</span></p></td><td style=\"width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"text-align:right\"><span>44,317</span></p></td></tr><tr><td style=\"width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>22</span></p></td><td style=\"width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Application fee under paragraph</span><span> </span><span>23B(2)(b) of the Act for an L(A)1 application</span></p></td><td style=\"width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"text-align:right\"><span>537</span></p></td></tr><tr><td style=\"width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>23</span></p></td><td style=\"width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Evaluation fee under subsection</span><span> </span><span>26AC(2) of the Act for an L(A)1 application</span></p></td><td style=\"width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"text-align:right\"><span>2,041</span></p></td></tr><tr><td style=\"width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>24</span></p></td><td style=\"width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Application fee under paragraph</span><span> </span><span>23B(2)(b) of the Act for an L(A)2 application</span></p></td><td style=\"width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"text-align:right\"><span>2,204</span></p></td></tr><tr><td style=\"width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>25</span></p></td><td style=\"width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Evaluation fee under subsection</span><span> </span><span>26AC(2) of the Act for an L(A)2 application</span></p></td><td style=\"width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"text-align:right\"><span>16,911</span></p></td></tr><tr><td style=\"width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>26</span></p></td><td style=\"width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Application fee under paragraph</span><span> </span><span>23B(2)(b) of the Act for an L(A)3 application</span></p></td><td style=\"width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"text-align:right\"><span>2,204</span></p></td></tr><tr><td style=\"width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>27</span></p></td><td style=\"width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Evaluation fee under subsection</span><span> </span><span>26AC(2) of the Act for an L(A)3 application</span></p></td><td style=\"width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"text-align:right\"><span>16,911</span></p></td></tr><tr><td style=\"width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>28</span></p></td><td style=\"width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Application fee under paragraph</span><span> </span><span>26BD(3)(c) of the Act for an IN1 application</span></p></td><td style=\"width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"text-align:right\"><span>1,307</span></p></td></tr><tr><td style=\"width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>29</span></p></td><td style=\"width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Evaluation fee under paragraph</span><span> </span><span>26BE(3)(b) of the Act for an IN1 application</span></p></td><td style=\"width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"text-align:right\"><span>17,611</span></p></td></tr><tr><td style=\"width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>30</span></p></td><td style=\"width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Application fee under paragraph</span><span> </span><span>26BD(3)(c) of the Act for an IN2 application</span></p></td><td style=\"width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"text-align:right\"><span>1,307</span></p></td></tr><tr><td style=\"width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>31</span></p></td><td style=\"width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Evaluation fee under paragraph</span><span> </span><span>26BE(3)(b) of the Act for an IN2 application</span></p></td><td style=\"width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"text-align:right\"><span>17,611</span></p></td></tr><tr><td style=\"width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>32</span></p></td><td style=\"width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Application fee under paragraph</span><span> </span><span>26BD(3)(c) of the Act for an IN3 application</span></p></td><td style=\"width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"text-align:right\"><span>3,463</span></p></td></tr><tr><td style=\"width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>33</span></p></td><td style=\"width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Evaluation fee under paragraph</span><span> </span><span>26BE(3)(b) of the Act for an IN3 application</span></p></td><td style=\"width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"text-align:right\"><span>28,690</span></p></td></tr><tr><td style=\"width:7.56%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>34</span></p></td><td style=\"width:79.48%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Application fee under paragraph</span><span> </span><span>26BD(3)(c) of the Act for an IN4 application</span></p></td><td style=\"width:12.96%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"text-align:right\"><span>3,463</span></p></td></tr><tr><td style=\"width:7.56%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>35</span></p></td><td style=\"width:79.48%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Evaluation fee under paragraph</span><span> </span><span>26BE(3)(b) of the Act for an IN4 application</span></p></td><td style=\"width:12.96%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"text-align:right\"><span>28,690</span></p></td></tr></tbody></table>\n```\n\n","sortOrder":4},{"sectionNumber":"Sch 9A","sectionType":"schedule","heading":"Fees—biologicals","content":"Schedule 9A—Fees—biologicals\n\n(regulation 43)\n\n## Part 1 Interpretation of table\n\n## Part 1—Interpretation of table\n\n## 1 Definitions\n\n#### 1 Definitions\n\n  In this table:\n\n> major variation, for a biological, means a change to the entry of the biological in the Register for any of the following, other than a change that would result in the biological becoming separate and distinct from other biologicals:\n\n    (a) a change requiring submission and evaluation of clinical data;\n    (c) a new strength;\n    (d) a new route of administration;\n    (e) a change in the intended patient group;\n    (f) a change in dosage.\n\n> minor variation, for a biological, means a change to the entry of the biological in the Register that requires the evaluation of quality and manufacturing information, other than a change that is a major variation for the biological or that would result in the biological becoming separate and distinct from other biologicals.\n\n## Part 2 Table of fees\n\n## Part 2—Table of fees\n\n| Item | Matter                                                                                                                                                                                                                                                                                          | Fee $                                                                                                                                  |\n| ---- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------- |\n| 1    | Application for inclusion of a Class 1 biological in the Register for paragraph 32DA(2)(d) of the Act                                                                                                                                                                                           | 1,330 for each application                                                                                                             |\n| 2    | Application for inclusion of a Class 2, Class 3 or Class 4 biological in the Register for paragraph 32DDA(2)(b) of the Act                                                                                                                                                                      | 1,330 for each application                                                                                                             |\n| 2AA  | Application fee for the purposes of paragraph 32DCA(2)(c) of the Act for an application to include an export only biological in the Register                                                                                                                                                    | 1,330 for each application                                                                                                             |\n| 2A   | Application fee for the purposes of paragraph 32DEA(3)(d) of the Act for a biologicals (priority applicant) determination in relation to a biological                                                                                                                                           | 15,880                                                                                                                                 |\n| 3    | Application for a manufacturing licence for paragraph 37(1)(g) of the Act                                                                                                                                                                                                                       | 1,330 for each application                                                                                                             |\n| 3A   | Fee for a notice and declaration under subregulation 43AAE(2) relating to an exemption from liability to pay an annual charge for inclusion of a biological in the Register for a financial year:                                                                                               |                                                                                                                                        |\n|      | (a) if the notice and declaration relate to not more than 5 entries in the Register                                                                                                                                                                                                             | 512                                                                                                                                    |\n|      | (b) if the notice and declaration relate to 6 or more entries in the Register                                                                                                                                                                                                                   | 512 for the first 5 entries plus 59 for each additional entry                                                                          |\n| 4    | Evaluation of a Class 2 biological for inclusion in the Register for subsection 32DI(1) of the Act:                                                                                                                                                                                             |                                                                                                                                        |\n|      | (a) for a biological in relation to which a biologicals (priority applicant) determination is in place                                                                                                                                                                                          | 92,524 for each evaluation                                                                                                             |\n|      | (b) in any other case                                                                                                                                                                                                                                                                           | 88,517 for each evaluation                                                                                                             |\n| 5    | Evaluation of a Class 3 biological for inclusion in the Register for subsection 32DI(1) of the Act:                                                                                                                                                                                             |                                                                                                                                        |\n|      | (a) for a biological in relation to which a biologicals (priority applicant) determination is in place                                                                                                                                                                                          | 185,504 for each evaluation                                                                                                            |\n|      | (b) in any other case                                                                                                                                                                                                                                                                           | 177,152 for each evaluation                                                                                                            |\n| 6    | Evaluation of a Class 4 biological for inclusion in the Register for subsection 32DI(1) of the Act:                                                                                                                                                                                             |                                                                                                                                        |\n|      | (a) for a biological in relation to which a biologicals (priority applicant) determination is in place                                                                                                                                                                                          | 299,757 for each evaluation                                                                                                            |\n|      | (b) in any other case                                                                                                                                                                                                                                                                           | 287,829 for each evaluation                                                                                                            |\n| 7    | Evaluation of an ingredient or component of a biological under regulation 16GF, for use in multiple biologicals (for which application for registration would later be made)                                                                                                                    | 28,806 for each evaluation                                                                                                             |\n| 8    | Application under subsection 9D(3AA) or (3A) of the Act to vary the entry of a biological in the Register                                                                                                                                                                                       | 1,330 for each application                                                                                                             |\n| 8A   | Evaluation of an application under subsection 9D(3AA) of the Act to vary the entry of a biological in the Register                                                                                                                                                                              | 8,117 for each evaluation                                                                                                              |\n| 9    | Evaluation of an application under subsection 9D(3A) of the Act to vary the entry of a Class 2 biological in the Register                                                                                                                                                                       | 8,117 for each evaluation                                                                                                              |\n| 10   | Evaluation of an application under subsection 9D(3A) of the Act to vary the entry of a Class 3 or Class 4 biological in the Register, if the variation is a minor variation                                                                                                                     | 21,342 for each evaluation                                                                                                             |\n| 11   | Evaluation of an application under subsection 9D(3A) of the Act to vary the entry of a Class 3 or Class 4 biological in the Register, if the variation is a major variation                                                                                                                     | 41,985 for each evaluation                                                                                                             |\n| 11A  | Application fee for processing an application for consent under section 14 or 14A of the Act:                                                                                                                                                                                                   |                                                                                                                                        |\n|      | (a) for an application relating to goods that are biologicals to which a single entry in the Register relates                                                                                                                                                                                   | 583 (for all the goods to which the application relates)                                                                               |\n|      | (b) for an application relating to goods that are biologicals to which both of the following apply:(i) there are separate entries in the Register in relation to the goods;(ii) the way in which the goods do not conform with a standard applicable to the goods is the same for all the goods | 583 for the first entry plus 117 for each additional entry                                                                             |\n| 12   | Inspection fee—initial manufacturing audit (Australia and overseas) for paragraphs 32DE (1) (e), 38(1)(c) and 58(3)(b) of the Act                                                                                                                                                               | 26,240 for each inspection                                                                                                             |\n| 13   | Inspection fee—subsequent Manufacturing Audit (Australia and overseas) for paragraphs 41 (1)(f) and 58(3)(b) of the Act                                                                                                                                                                         | 19,942 for each inspection                                                                                                             |\n| 14   | Inspection fee—in addition to an inspection fee mentioned in item 12 or 13 above for an inspection that is required to be conducted outside Australia                                                                                                                                           | 815 for each hour of preparation by each inspector                                                                                     |\n| 15   | Inspection fee—in addition to an inspection fee mentioned in item 12 or 13 above for an inspection that is required to be conducted outside Australia                                                                                                                                           | Amount of costs and reasonable expenses of travel by each inspector, including costs for accommodation and allowance outside Australia |\n| 16   | Evaluation fee for subsection 32CK(4) of the Act                                                                                                                                                                                                                                                | 31,955 for each evaluation                                                                                                             |\n| 16AA | Fee for the purposes of paragraph 32CK(9A)(e) of the Act, for a request under subsection 32CK(9A) of the Act to vary the biological specified in an approval to use the biological solely for experimental purposes in humans, or to vary the conditions of such an approval                    | 8,718                                                                                                                                  |\n| 16A  | Application fee for a request, under subsection 32GD(1) of the Act, for the revocation of the cancellation of an entry of a biological from the Register:                                                                                                                                       |                                                                                                                                        |\n|      | (a) if the request relates to one entry;                                                                                                                                                                                                                                                        | 187                                                                                                                                    |\n|      | (b) if the request relates to more than one entry                                                                                                                                                                                                                                               | 187 for the first entry plus 59 for each additional entry                                                                              |\n| 16B  | Application fee for a request, under subsection 32GDA(1) of the Act, for the revocation of the cancellation of an entry of a biological from the Register:                                                                                                                                      |                                                                                                                                        |\n|      | (a) if the request relates to one entry;                                                                                                                                                                                                                                                        | 187                                                                                                                                    |\n|      | (b) if the request relates to more than one entry                                                                                                                                                                                                                                               | 187 for the first entry plus 59 for each additional entry                                                                              |\n| 17   | Fee for notification required under item 3 of Schedule 5A for a biological to which that Schedule applies:                                                                                                                                                                                      |                                                                                                                                        |\n|      | (a) of intention to sponsor a clinical trial at a trial site using a biological                                                                                                                                                                                                                 | 443                                                                                                                                    |\n|      | (b) for each notification of an additional trial site or additional trial sites                                                                                                                                                                                                                 | 443                                                                                                                                    |\n\n","sortOrder":5},{"sectionNumber":"Sch 10","sectionType":"schedule","heading":"Therapeutic goods for evaluation","content":"Schedule 10—Therapeutic goods for evaluation\n\nNote: See regulations 16C, 16D, 16F, 16G and 45.\n\n## Part 1 Evaluation of prescription and other medicines by the Prescription Medicines Authorisation Branch\n\n## Part 1—Evaluation of prescription and other medicines by the Prescription Medicines Authorisation Branch\n\n| Column 1Item | Column 2Product                                                                                                                                                                                                                                                                                                     |\n| ------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |\n| 1            | therapeutic goods (except therapeutic goods mentioned in another Part of this Schedule), that:(a) contain a substance mentioned in Schedule 4, 8 or 9 to the Poisons Standard; or(b) contain a substance not mentioned in any of those Schedules but which meets the criteria for mention in any of those Schedules |\n| 2            | a medical gas                                                                                                                                                                                                                                                                                                       |\n| 3            | a vaccine                                                                                                                                                                                                                                                                                                           |\n| 4            | an allergen, except an allergen for skin patch testing on unbroken skin                                                                                                                                                                                                                                             |\n| 5            | a biotechnology medicine                                                                                                                                                                                                                                                                                            |\n| 6            | an immunoglobulin                                                                                                                                                                                                                                                                                                   |\n| 7            | a radio contrast agent, except barium sulphate preparation for radiological use                                                                                                                                                                                                                                     |\n| 8            | a radiopharmaceutical                                                                                                                                                                                                                                                                                               |\n| 9            | a dialysis solution, except a haemodialysis solution                                                                                                                                                                                                                                                                |\n| 11           | a special dosage form, such as a transdermal system or osmotic pump                                                                                                                                                                                                                                                 |\n| 12           | an injectable medicine dosage form                                                                                                                                                                                                                                                                                  |\n| 13           | a blood product                                                                                                                                                                                                                                                                                                     |\n| 14           | therapeutic goods referred to the Prescription Medicines Authorisation Branch of the Therapeutic Goods Administration within the Department for the purpose of evaluation as a prescription medicine                                                                                                                |\n| 15           | an excipient in therapeutic goods mentioned in this Part                                                                                                                                                                                                                                                            |\n\n## Part 2 Evaluation of complementary medicines by the Complementary and OTC Medicines Branch\n\n## Part 2—Evaluation of complementary medicines by the Complementary and OTC Medicines Branch\n\n  The following therapeutic goods, if the sponsor has satisfied the Secretary that the goods do not meet the criteria for mention in Schedule 4, 8 or 9 of the Poisons Standard:\n\n| Column 1Item | Column 2Product                                                                                                                                       |\n| ------------ | ----------------------------------------------------------------------------------------------------------------------------------------------------- |\n| 1            | a complementary medicine                                                                                                                              |\n| 2            | an excipient in complementary medicine                                                                                                                |\n| 3            | therapeutic goods referred for evaluation to the Complementary and OTC Medicines Branch of the Therapeutic Goods Administration within the Department |\n\n## Part 3 Evaluation of non‑prescription and other medicines by the Complementary and OTC Medicines Branch\n\n## Part 3—Evaluation of non‑prescription and other medicines by the Complementary and OTC Medicines Branch\n\n  The following therapeutic goods, if the sponsor has satisfied the Secretary that the goods do not meet the criteria for mention in Schedule 4, 8 or 9 of the Poisons Standard:\n\n| Column 1Item | Column 2Product                                                                                                                                                                                     |\n| ------------ | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |\n| 1            | an antiseptic                                                                                                                                                                                       |\n| 2            | a sunscreen preparation                                                                                                                                                                             |\n| 3            | all other therapeutic goods not mentioned in another Part of this Schedule                                                                                                                          |\n| 4            | an excipient in therapeutic goods mentioned in this Part                                                                                                                                            |\n| 5            | therapeutic goods referred to the Complementary and OTC Medicines Branch of the Therapeutic Goods Administration within the Department for the purpose of evaluation as a non‑prescription medicine |\n\n## 1 General requirements\n\n#### 1 General requirements\n\n  A consumer medicine information document about a medicine must:\n    (a) be written in English; and\n    (b) be clearly legible; and\n    (c) be written in language that will easily be understood by patients; and\n    (d) be consistent with product information about the product.\n\n## 2 Specific requirements—document enclosed within packaging etc.\n\n#### 2 Specific requirements—document enclosed within packaging etc.\n\n  Also, if the consumer medicine information document about a medicine is enclosed within, on a surface of, or affixed to a surface of, the packaging of the medicine, it must set out all of the information required by the “TGA Consumer Medicine Information (Prescription Medicine) Template” (published by the Therapeutic Goods Administration on its website) but:\n    (a) it is not required to set out the information in the same order as the Template; and\n    (b) it is not required to include any Consumer Medicine Information (CMI) summary that forms part of that Template.\n\n## 3 Specific requirements—document not enclosed within packaging etc.\n\n#### 3 Specific requirements—document not enclosed within packaging etc.\n\n  Also, if the consumer medicine information document about a medicine is not enclosed within, on a surface of, or affixed to a surface of, the packaging of the medicine:\n    (a) it must set out all of the information required by the “TGA Consumer Medicine Information (Prescription Medicine) Template” (published by the Therapeutic Goods Administration on its website) in the same order as the Template; and\n    (b) if it is supplied in electronic form, it must be in the form of a PDF file or an HTML file.\n\n","sortOrder":6},{"sectionNumber":"Sch 13","sectionType":"schedule","heading":"Consumer medicine information documents","content":"Schedule 13—Consumer medicine information documents\n\nNote: See subregulation 9A(1A).\n\n## 1 General requirements\n\n#### 1 General requirements\n\n  A consumer medicine information document about a medicine must:\n    (a) be written in English; and\n    (b) be clearly legible; and\n    (c) be written in language that will easily be understood by patients; and\n    (d) be consistent with product information about the product.\n\n## 2 Specific requirements—document enclosed within packaging etc.\n\n#### 2 Specific requirements—document enclosed within packaging etc.\n\n  Also, if the consumer medicine information document about a medicine is enclosed within, on a surface of, or affixed to a surface of, the packaging of the medicine, it must set out all of the information required by the “TGA Consumer Medicine Information (Non‑prescription Medicine) Template” (published by the Therapeutic Goods Administration on its website) but:\n    (a) it is not required to set out the information in the same order as the Template; and\n    (b) it is not required to include any Consumer Medicine Information (CMI) summary that forms part of that Template.\n\n## 3 Specific requirements—document not enclosed within packaging etc.\n\n#### 3 Specific requirements—document not enclosed within packaging etc.\n\n  Also, if the consumer medicine information document about a medicine is not enclosed within, on a surface of, or affixed to a surface of, the packaging of the medicine:\n    (a) it must set out all of the information required by the “TGA Consumer Medicine Information (Non‑prescription Medicine) Template” (published by the Therapeutic Goods Administration on its website) in the same order as the Template; and\n    (b) if it is supplied in electronic form, it must be in the form of a PDF file or an HTML file.\n\n## 1A Class 1 biologicals\n\n#### 1A Class 1 biologicals\n\n  For the purposes of the definition of Class 1 biological in regulation 2, a biological is a Class 1 biological if:\n    (a) it is a faecal microbiota transplant product; and\n    (b) it is not advertised to consumers; and\n    (c) it is to be collected under the supervision or direction, or in accordance with the requirements, of a medical practitioner registered, in a State or internal Territory, as a medical practitioner; and\n    (d) each later step in the manufacture of it is to be carried out in a hospital by, or under the supervision or direction of, the practitioner (unless the step relates to the storage or testing of the biological, in which case it may instead be carried out by a person under a contract with the hospital in a State or internal Territory); and\n    (e) it is for use in a recipient who is a patient of the hospital with the recipient being under the clinical care of the practitioner.\n\n## 1 Class 4 biologicals\n\n#### 1 Class 4 biologicals\n\n  For the purposes of the definition of Class 4 biological in regulation 2, the following biologicals are Class 4 biologicals:\n    (a) biologicals that comprise or contain:\n    (i) live animal cells; or\n    (ii) live animal tissues; or\n    (iii) live animal organs;\n    (b) biologicals to which both of the following paragraphs apply:\n    (i) the biologicals comprise, contain or are derived from human cells or human tissues that have been modified to artificially introduce a function or functions of the cells or tissues;\n    (ii) the artificially introduced function or functions were not intrinsic to the cells or tissues when they were collected from the donor;\n    (c) pluripotent stem cells;\n    (d) biologicals derived from pluripotent stem cells.","sortOrder":7}],"analysis":{"kimi_summary":{"content_quality":"ok","complexity_score":9,"scope_assessment":{"changed":true,"description":"The regulations have expanded significantly beyond their original 1990 scope. Originally focused on traditional medicines and medical devices, they now cover: therapeutic vaping products (reflecting recent public health concerns), faecal microbiota transplant products (emerging biotechnology), biological medicines and cell/tissue therapies (advanced therapeutic goods), mercury-containing products (international treaty obligations under Minamata Convention), and complex application pathways for complementary medicines. The inclusion of vaping regulations and faecal transplants demonstrates how the regulations have grown to address novel therapeutic categories and public health challenges that didn't exist when the regulations were first made."},"complexity_factors":["Over 100 defined terms in the interpretation section, many with nested sub-definitions and cross-references to other regulations","Multiple parallel classification systems for applications (C1-C4, N1-N5, L(A)1-L(A)3, L(A)C1-L(A)CN, RCM1-RCM5, RCMC1-RCMC4, IN1-IN4) creating a labyrinthine application pathway structure","Extensive cross-referencing to the Therapeutic Goods Act 1989, Therapeutic Goods (Medical Devices) Regulations 2002, Poisons Standard, and various State and Territory laws","Conditional logic with multiple exceptions (e.g., regulation 3AA has four alternative pathways with nested sub-conditions)","Tables and schedules referenced throughout but not included in the excerpt (Schedules 1-16, changes table, etc.)","Technical scientific definitions requiring specialised knowledge (bioequivalence, homologous use, minimal manipulation, sterility assurance levels)","Strict liability offences with evidential burdens and defences creating complex criminal law interactions","Dynamic references to documents 'as in force from time to time' (Australian Approved Names List, TGA notifications process guidance document, Minamata Convention)","Duplicated content in the excerpt suggesting the full regulations are extremely lengthy with repeated definitions across parts"],"plain_english_summary":"These are the Therapeutic Goods Regulations 1990, which set out the detailed rules for how medicines, medical devices, and other therapeutic goods are regulated in Australia. They work alongside the Therapeutic Goods Act 1989 to establish the framework for:\n\n**What the regulations cover:**\n- **Definitions**: Extensive definitions of terms like 'medicine', 'biological', 'disinfectant', 'complementary medicine', and newer categories like 'therapeutic vaping goods' and 'faecal microbiota transplant products'.\n- **Registration and listing**: Different categories of applications for getting products onto the Australian Register of Therapeutic Goods (ARTG), including complex classification systems (C1-C4, L(A)1-L(A)3, RCM1-RCM5, etc.) that determine how rigorously a product must be evaluated.\n- **Advertising rules**: Restrictions on how therapeutic goods can be advertised to the public, including prohibited representations and requirements for certain advisory statements.\n- **Patient information**: Requirements for consumer medicine information documents to be supplied with certain medicines.\n- **Biologicals**: Special rules for products made from human cells and tissues, including definitions of 'minimal manipulation' and 'homologous use'.\n- **Safety and quality**: Standards for presentation (e.g., banning packaging that looks like confectionery), storage conditions, and manufacturing.\n\n**Who it affects:**\n- Pharmaceutical companies and sponsors seeking to register or list products in Australia\n- Manufacturers of therapeutic goods\n- Healthcare practitioners\n- Consumers who use medicines, medical devices, and other therapeutic goods\n- State and territory health departments (through 'corresponding State law' provisions)\n\n**Why it matters:**\nThese regulations determine what products can legally be sold in Australia, how they must be labelled, what safety information must be provided, and how they can be advertised. Recent updates include provisions for therapeutic vaping products, faecal microbiota transplants, and mercury-containing products under the Minamata Convention."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-regulations-1990","history":"/api/acts/therapeutic-goods-regulations-1990/history","analysis":"/api/acts/therapeutic-goods-regulations-1990/analysis","conflicts":"/api/acts/therapeutic-goods-regulations-1990/conflicts","importantCases":"/api/acts/therapeutic-goods-regulations-1990/important-cases","documents":"/api/acts/therapeutic-goods-regulations-1990/documents"}}